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Roxee Meds Catalog

Melarsomine Dihydrochloride

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Catalog complete FDA data linked Rx required Powder Anzac Animal Health, LLC Official label facts Owner quick guide first
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Data freshness

Storefront facts
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FDA applications
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May 5, 2026, 10:00 a.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
Safety data refreshed
May 5, 2026, 10:01 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Storefront facts: Source Roxee | Refreshed Apr 22, 2026, 10:07 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: April 15, 2026

Updated: April 15, 2026, 10:04 AM UTC

Sources:
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Melarsomine Dihydrochloride

Melarsomine Dihydrochloride

Drug type: Generic ingredient • Generic profile • No FDA branded products linked

Both Powder Rx required 100% storefront ready

Species: Both

Manufacturer: Anzac Animal Health, LLC

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Melarsomine Dihydrochloride

Treatment of stabilized, class 1, 2, and 3 heartworm disease (asymptomatic to mild, moderate, and severe, respectively) caused by immature (4 month-old, stage L5) to mature adult infections of Dirofilaria immitis in dogs. For the treatment of stabilized Class 1, 2, and 3 heartworm disease caused by immature (4 month-old, stage L5) to mature adult infections of Dirofilaria immitis . Species commonly shown: Both, Dog, No Use Class Stated Or Implied.

Generic name
Melarsomine Dihydrochloride
Brand names
DIROBAN®
Manufacturer
Anzac Animal Health, LLC
Species
Both, Dog, No Use Class Stated Or Implied
Dosage forms
Powder
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
DIROBAN®
Dosage forms
Powder

Indications / Uses

Treatment of stabilized, class 1, 2, and 3 heartworm disease (asymptomatic to mild, moderate, and severe, respectively) caused by immature (4 month-old, stage L5) to mature adult infections of Dirofilaria immitis in dogs. For the treatment of stabilized Class 1, 2, and 3 heartworm disease caused by immature (4 month-old, stage L5) to mature adult infections of Dirofilaria immitis .

Warnings / Contraindications

Administer only by deep intramuscular injection in the lumbar muscles (L3 - L4). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/2 inch needle for dogs greater than 10 kilograms (22 pounds). Use in alternate sides with each administration. The drug is contraindicated in dogs with class 4 (very severe) heartworm disease (Caval Syndrome). Not for use in breeding animals and lactating or pregnant bitches. IMMITICIDE® should be administered by deep intramuscular injection in the lumbar (epaxial) muscles (L3 - L5) ONLY. DO NOT USE IN ANY OTHER MUSCLE GROUP. DO NOT USE INTRAVENOUSLY. Care should be taken to avoid superficial injection or leakage. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in breeding animals and lactating or pregnant bitches. The drug is contraindicated in dogs with class 4 (very severe) heartworm disease (Caval Syndrome). Administer only by deep intramuscular injection in the lumbar muscles (L3 – L5). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/2 inch needle for dogs greater than 10 kilograms (22 pounds). Use in alternate sides with each administration. DIROBANTM should be administered by deep intramuscular injection in the lumbar (epaxial) muscles (L3 - L5) ONLY. DO NOT USE IN ANY OTHER MUSCLE GROUP. DO NOT USE INTRAVENOUSLY. Care should be taken to avoid superficial injection or leakage. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • Administer only by deep intramuscular injection in the lumbar muscles (L3 - L4). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/2 inch needle for dogs greater than 10 kilograms (22 pounds). Use in alternate sides with each administration. The drug is contraindicated in dogs with class 4 (very severe) heartworm disease (Caval Syndrome). Not for use in breeding animals and lactating or pregnant bitches. IMMITICIDE® should be administered by deep intramuscular injection in the lumbar (epaxial) muscles (L3 - L5) ONLY. DO NOT USE IN ANY OTHER MUSCLE GROUP. DO NOT USE INTRAVENOUSLY. Care should be taken to avoid superficial injection or leakage. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in breeding animals and lactating or pregnant bitches. The drug is contraindicated in dogs with class 4 (very severe) heartworm disease (Caval Syndrome). Administer only by deep intramuscular injection in the lumbar muscles (L3 – L5). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/2 inch needle for dogs greater than 10 kilograms (22 pounds). Use in alternate sides with each administration. DIROBANTM should be administered by deep intramuscular injection in the lumbar (epaxial) muscles (L3 - L5) ONLY. DO NOT USE IN ANY OTHER MUSCLE GROUP. DO NOT USE INTRAVENOUSLY. Care should be taken to avoid superficial injection or leakage. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Lack of efficacy (endoparasite) - heartworm, Vomiting, Injection site swelling, INEFFECTIVE, HEARTWORM ADULTS, Lethargy (see also Central nervous system depression in 'Neurological'), Injection site lump.

FAQ

Both, Dog, No Use Class Stated Or Implied

Yes. Roxee shows this as prescription-only.

Powder

Related Conditions

Heartworm Disease

Source Transparency

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Pet Owner Quick Guide

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Used for:

For the treatment of stabilized Class 1, 2, and 3 heartworm disease caused by immature (4 month-old, stage L5) to mature adult infections of Dirofilaria immitis .

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • Administer only by deep intramuscular injection in the lumbar muscles (L3 - L4)
  • Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/2 inch needle for dogs greater than 10 kilograms (22 pounds)
  • Use in alternate sides with each administration
  • The drug is contraindicated in dogs with class 4 (very severe) heartworm disease (Caval Syndrome)
  • Not for use in breeding animals and lactating or pregnant bitches
  • IMMITICIDE® should be administered by deep intramuscular injection in the lumbar (epaxial) muscles (L3 - L5) ONLY
  • DO NOT USE IN ANY OTHER MUSCLE GROUP
  • DO NOT USE INTRAVENOUSLY
  • Care should be taken to avoid superficial injection or leakage
  • Administer only by deep intramuscular injection in the lumbar muscles (L3 – L5)
  • DIROBANTM should be administered by deep intramuscular injection in the lumbar (epaxial) muscles (L3 - L5) ONLY
  • Vomiting (1 reports)
  • trouble breathing (1 reports)
  • Increased lung sounds (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Facial swelling or hives.
  • Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?
Major cautions & emergency warning signs

Side effects to monitor:

  • Administer only by deep intramuscular injection in the lumbar muscles (L3 - L4)
  • Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/2 inch needle for dogs greater than 10 kilograms (22 pounds)
  • Use in alternate sides with each administration
  • The drug is contraindicated in dogs with class 4 (very severe) heartworm disease (Caval Syndrome)
  • Not for use in breeding animals and lactating or pregnant bitches

Most reported reactions:

  • Vomiting (1 reports)
  • Trouble breathing (dyspnea) (1 reports)
  • Increased lung sounds (1 reports)

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Facial swelling or hives.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Anzac Animal Health, LLC
Form: Powder
Identifiers:
ANADA: 200609 NADA: 141042 NDC Package: 54771-1920-1 NDC Product: 54771
Source metadata:

Warnings / Contraindications

Administer only by deep intramuscular injection in the lumbar muscles (L3 - L4). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/2 inch needle for dogs greater than 10 kilograms (22 pounds). Use in alternate sides with each administration. The drug is contraindicated in dogs with class 4 (very severe) heartworm disease (Caval Syndrome). Not for use in breeding animals and lactating or pregnant bitches. IMMITICIDE® should be administered by deep intramuscular injection in the lumbar (epaxial) muscles (L3 - L5) ONLY. DO NOT USE IN ANY OTHER MUSCLE GROUP. DO NOT USE INTRAVENOUSLY. Care should be taken to avoid superficial injection or leakage. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in breeding animals and lactating or pregnant bitches. The drug is contraindicated in dogs with class 4 (very severe) heartworm disease (Caval Syndrome). Administer only by deep intramuscular injection in the lumbar muscles (L3 – L5). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/2 inch needle for dogs greater than 10 kilograms (22 pounds). Use in alternate sides with each administration. DIROBANTM should be administered by deep intramuscular injection in the lumbar (epaxial) muscles (L3 - L5) ONLY. DO NOT USE IN ANY OTHER MUSCLE GROUP. DO NOT USE INTRAVENOUSLY. Care should be taken to avoid superficial injection or leakage. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: Administer only by deep intramuscular injection in the lumbar muscles (L3 - L4). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/2 inch needle for dogs greater than 10 kilograms (22 pounds). Use in alternate sides with each administration. The drug is contraindicated in dogs with class 4 (very severe) heartworm disease (Caval Syndrome). Not for use in breeding animals and lactating or pregnant bitches. IMMITICIDE® should be administered by deep intramuscular injection in the lumbar (epaxial) muscles (L3 - L5) ONLY. DO NOT USE IN ANY OTHER MUSCLE GROUP. DO NOT USE INTRAVENOUSLY. Care should be taken to avoid superficial injection or leakage. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in breeding animals and lactating or pregnant bitches. The drug is contraindicated in dogs with class 4 (very severe) heartworm disease (Caval Syndrome). Administer only by deep intramuscular injection in the lumbar muscles (L3 – L5). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/2 inch needle for dogs greater than 10 kilograms (22 pounds). Use in alternate sides with each administration. DIROBANTM should be administered by deep intramuscular injection in the lumbar (epaxial) muscles (L3 - L5) ONLY. DO NOT USE IN ANY OTHER MUSCLE GROUP. DO NOT USE INTRAVENOUSLY. Care should be taken to avoid superficial injection or leakage. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
30
Species represented
2
Grouped by Body System
Digestive (3) · Vomiting, Drooling, Diarrhea Skin & allergy (1) · Generalised rash Behavior (1) · Biting -aggression Other (27) · Trouble breathing (dyspnea), Injection site lump, Increased lung sounds
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1

Species coverage: Dog (29) Cat (3)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Dog Serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Skin & allergy Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Digestive Dog Serious - 1
Other Dog Non-serious - 1
Digestive Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Behavior Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Source metadata:

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

1

FOI

1

DIROBAN®

SPL · SPL

Open original
FDA Structured Product Label

DIROBAN®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Anzac Animal Health, LLC
ANADA
200-609
Status
RX
Form
Powder
Route
Intramuscular
Species
Dog, No Use Class Stated Or Implied
Composition / specifications
Contains 50.0 mg melarsomine dihydrochloride and 33.75 mg glycine USP. 1 vial: when reconstituted with 2 mL of sterile water for injection (provided) contains 25 mg/mL of active ingredient.

Dogs

Indication

For the treatment of stabilized Class 1, 2, and 3 heartworm disease caused by immature (4 month-old, stage L5) to mature adult infections of Dirofilaria immitis.

Dosage

For severe (class 3) heartworm disease: administer a single injection of 2.5 mg/kg then approximately 1 month later with 2.5 mg/kg administered twice 24 hours apart.

For asymptomatic to moderate (class 1 to 2) heartworm disease: administer 2.5 mg/kg intramuscularly in the lumbar (L3 - L5) muscles twice, 24 hours apart. Four months following treatment, a second treatment series (2.5 mg/kg twice, 24 hours apart) can be elected taking into consideration the response to the first treatment and the condition, age, and use of the dog.

Limitations

Not for use in breeding animals and lactating or pregnant bitches. The drug is contraindicated in dogs with class 4 (very severe) heartworm disease (Caval Syndrome). Administer only by deep intramuscular injection in the lumbar muscles (L3 – L5). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/2 inch needle for dogs greater than 10 kilograms (22 pounds). Use in alternate sides with each administration. DIROBANTM should be administered by deep intramuscular injection in the lumbar (epaxial) muscles (L3 - L5) ONLY. DO NOT USE IN ANY OTHER MUSCLE GROUP. DO NOT USE INTRAVENOUSLY. Care should be taken to avoid superficial injection or leakage. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FOI Summary oA 200-609 Approved February 17, 2017.pdf

FOI · FOI

Open original
Source metadata:
Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Storefront facts: Source Roxee | Refreshed Apr 22, 2026, 10:07 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Powder • Intramuscular
Applications: ANADA 200-609
Documents: 1 (FOI: 1) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 49 • Cat 0 • View
Case summaries: 10 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Heartworm Disease
Linked using: Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: B74.8
Other filariases

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Administer only by deep intramuscular injection in the lumbar muscles (L3 - L4). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/2 inch needle for dogs greater than 10 kilograms (22 pounds). Use in alternate sides with each administration. The drug is contraindicated in dogs with class 4 (very severe) heartworm disease (Caval Syndrome). Not for use in breeding animals and lactating or pregnant bitches. IMMITICIDE® should be administered by deep intramuscular injection in the lumbar (epaxial) muscles (L3 - L5) ONLY. DO NOT USE IN ANY OTHER MUSCLE GROUP. DO NOT USE INTRAVENOUSLY. Care should be taken to avoid superficial injection or leakage. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in breeding animals and lactating or pregnant bitches. The drug is contraindicated in dogs with class 4 (very severe) heartworm disease (Caval Syndrome). Administer only by deep intramuscular injection in the lumbar muscles (L3 – L5). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/2 inch needle for dogs greater than 10 kilograms (22 pounds). Use in alternate sides with each administration. DIROBANTM should be administered by deep intramuscular injection in the lumbar (epaxial) muscles (L3 - L5) ONLY. DO NOT USE IN ANY OTHER MUSCLE GROUP. DO NOT USE INTRAVENOUSLY. Care should be taken to avoid superficial injection or leakage. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Vomiting (1) Trouble breathing (dyspnea) (1) Increased lung sounds (1) Inappetence (1) Icterus (1) Hepatitis (1) Hepatic fibrosis (1) Heavy breathing (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
ANADA: 200609 NADA: 141042 NDC Package: 54771-1920-1 NDC Product: 54771
Package NDC Product NDC Form / Route Status
54771-1920-1 54771 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 20 Clinical 9 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Administer only by deep intramuscular injection in the lumbar muscles (L3 - L4). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 p… (Clinical, 2026-04-15)
  • contraindications: Administer only by deep intramuscular injection in the lumbar muscles (L3 - L4). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 p… (Clinical, 2026-04-15)
  • contraindications: Administer only by deep intramuscular injection in the lumbar muscles (L3 - L4). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 p… (Clinical, 2026-04-11)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy (endoparasite) - heartworm, Vomiting, Injection site swelling, INEFFECTIVE, HEARTWORM ADULTS, Lethargy (see … (Clinical, 2026-04-11)
  • usage: Treatment of stabilized, class 1, 2, and 3 heartworm disease (asymptomatic to mild, moderate, and severe, respectively) caused by immature (4 month-old, stage … (Clinical, 2026-04-15)
  • usage: Treatment of stabilized, class 1, 2, and 3 heartworm disease (asymptomatic to mild, moderate, and severe, respectively) caused by immature (4 month-old, stage … (Clinical, 2026-04-15)
  • usage: Treatment of stabilized, class 1, 2, and 3 heartworm disease (asymptomatic to mild, moderate, and severe, respectively) caused by immature (4 month-old, stage … (Clinical, 2026-04-11)
  • contraindications: Administer only by deep intramuscular injection in the lumbar muscles (L3 - L4). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 p… (Official, 2026-04-22)
  • contraindications: Administer only by deep intramuscular injection in the lumbar muscles (L3 - L4). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 p… (Official, 2026-02-12)
  • indications: DIROBAN Sterile Powder for Injection is indicated for the treatment of stabilized Class 1, 2, and 3 heartworm disease caused by immature (4 month-old, stage L5… (Official, 2026-05-05)
  • indications: DIROBAN Sterile Powder for Injection is indicated for the treatment of stabilized Class 1, 2, and 3 heartworm disease caused by immature (4 month-old, stage L5… (Official, 2026-05-03)
  • indications: DIROBAN Sterile Powder for Injection is indicated for the treatment of stabilized Class 1, 2, and 3 heartworm disease caused by immature (4 month-old, stage L5… (Official, 2026-05-02)
  • indications: DIROBAN Sterile Powder for Injection is indicated for the treatment of stabilized Class 1, 2, and 3 heartworm disease caused by immature (4 month-old, stage L5… (Official, 2026-04-29)
  • indications: DIROBAN Sterile Powder for Injection is indicated for the treatment of stabilized Class 1, 2, and 3 heartworm disease caused by immature (4 month-old, stage L5… (Official, 2026-04-28)
  • indications: DIROBAN Sterile Powder for Injection is indicated for the treatment of stabilized Class 1, 2, and 3 heartworm disease caused by immature (4 month-old, stage L5… (Official, 2026-04-27)
  • indications: DIROBAN Sterile Powder for Injection is indicated for the treatment of stabilized Class 1, 2, and 3 heartworm disease caused by immature (4 month-old, stage L5… (Official, 2026-04-26)
  • indications: DIROBAN Sterile Powder for Injection is indicated for the treatment of stabilized Class 1, 2, and 3 heartworm disease caused by immature (4 month-old, stage L5… (Official, 2026-04-25)
  • indications: DIROBAN Sterile Powder for Injection is indicated for the treatment of stabilized Class 1, 2, and 3 heartworm disease caused by immature (4 month-old, stage L5… (Official, 2026-04-22)
Recent Revisions
  • side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-16 13:27 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-16 13:27 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-16 13:27 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-16 13:27 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-16 13:27 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-16 13:27 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-15 10:06 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:06 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-15 10:06 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-15 10:06 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-15 10:06 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-15 10:06 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-15 10:06 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-15 10:06 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-15 10:06 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
DIROBAN®
RX
Melarsomine Dihydrochloride
Powder • Intramuscular
Label highlights
Official documents
Anzac Animal Health, LLC ANADA 200-609 Approved Jan 28, 2020

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Contains 50.0 mg melarsomine dihydrochloride and 33.75 mg glycine USP. 1 vial: when reconstituted with 2 mL of sterile water for injection (provided) contains 25 mg/mL of active ingredient.
Dogs
Indication

For the treatment of stabilized Class 1, 2, and 3 heartworm disease caused by immature (4 month-old, stage L5) to mature adult infections of Dirofilaria immitis.

Dosage

For severe (class 3) heartworm disease: administer a single injection of 2.5 mg/kg then approximately 1 month later with 2.5 mg/kg administered twice 24 hours apart.

For asymptomatic to moderate (class 1 to 2) heartworm disease: administer 2.5 mg/kg intramuscularly in the lumbar (L3 - L5) muscles twice, 24 hours apart. Four months following treatment, a second treatment series (2.5 mg/kg twice, 24 hours apart) can be elected taking into consideration the response to the first treatment and the condition, age, and use of the dog.

Limitations

Not for use in breeding animals and lactating or pregnant bitches. The drug is contraindicated in dogs with class 4 (very severe) heartworm disease (Caval Syndrome). Administer only by deep intramuscular injection in the lumbar muscles (L3 – L5). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/2 inch needle for dogs greater than 10 kilograms (22 pounds). Use in alternate sides with each administration. DIROBANTM should be administered by deep intramuscular injection in the lumbar (epaxial) muscles (L3 - L5) ONLY. DO NOT USE IN ANY OTHER MUSCLE GROUP. DO NOT USE INTRAVENOUSLY. Care should be taken to avoid superficial injection or leakage. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Usage

Treatment of stabilized, class 1, 2, and 3 heartworm disease (asymptomatic to mild, moderate, and severe, respectively) caused by immature (4 month-old, stage L5) to mature adult infections of Dirofilaria immitis in dogs. For the treatment of stabilized Class 1, 2, and 3 heartworm disease caused by immature (4 month-old, stage L5) to mature adult infections of Dirofilaria immitis .

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Administer only by deep intramuscular injection in the lumbar muscles (L3 - L4). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/2 inch needle for dogs greater than 10 kilograms (22 pounds). Use in alternate sides with each administration. The drug is contraindicated in dogs with class 4 (very severe) heartworm disease (Caval Syndrome). Not for use in breeding animals and lactating or pregnant bitches. IMMITICIDE® should be administered by deep intramuscular injection in the lumbar (epaxial) muscles (L3 - L5) ONLY. DO NOT USE IN ANY OTHER MUSCLE GROUP. DO NOT USE INTRAVENOUSLY. Care should be taken to avoid superficial injection or leakage. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in breeding animals and lactating or pregnant bitches. The drug is contraindicated in dogs with class 4 (very severe) heartworm disease (Caval Syndrome). Administer only by deep intramuscular injection in the lumbar muscles (L3 – L5). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/2 inch needle for dogs greater than 10 kilograms (22 pounds). Use in alternate sides with each administration. DIROBANTM should be administered by deep intramuscular injection in the lumbar (epaxial) muscles (L3 - L5) ONLY. DO NOT USE IN ANY OTHER MUSCLE GROUP. DO NOT USE INTRAVENOUSLY. Care should be taken to avoid superficial injection or leakage. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Vomiting (1) • Dog Drooling (1) • Dog Diarrhea (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Generalised rash (1) • Dog

Showing top 5 for Skin & allergy.

Behavior
Biting -aggression (1) • Dog

Showing top 5 for Behavior.

Other
Trouble breathing (1) • Dog Injection site lump (1) • Dog Increased lung sounds (1) • Dog Inappetence (1) • Dog Icterus (1) • Dog
Show more (22)
Hepatitis (1) • Dog Hepatic fibrosis (1) • Dog Heavy breathing (1) • Cat Haemorrhagic gastroenteritis (1) • Dog Groaning (1) • Dog Gastric distension (1) • Dog Erythema (1) • Dog Elevated total bilirubin (1) • Dog Elevated serum alkaline phosphatase (1) • Dog Elevated gamma-glutamyl transferase (1) • Dog Elevated alanine aminotransferase (1) • Dog Discomfort NOS (1) • Dog Death (1) • Cat Cough (1) • Dog Corneal ulcer (1) • Dog Cardiorespiratory arrest (1) • Cat Blood in faeces (1) • Dog Angioedema (1) • Dog Abnormal ultrasound finding (1) • Dog Abnormal radiograph finding (1) • Dog Abnormal posture NOS (1) • Dog Abnormal cytology (1) • Dog

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Dog, Shepherd Dog - German, Male, 5.5 year, 45.631 kilogram • Drug: MSK, Powder, Intramuscular, Dose: 4.60 mL per animal • Reactions: Drooling, Panting, Pacing, Uncomfortable • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075155
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 5.50 Year
  • Weight: 45.631 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Powder
  • Dose: 4.60 mL per animal
Reactions Reported:
Drooling Panting Pacing Uncomfortable
Outcomes: Ongoing

Dog, ['Terrier - Jack Russell', 'Dog (unknown)'], Female, 3.5 year, 8.437 kilogram • Drug: MSK, Powder, Intramuscular, Dose: 0.65 mL per animal • Reactions: Lack of efficacy (endoparasite) - heartworm • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075154
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 3.50 Year
  • Weight: 8.437 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Powder
  • Dose: 0.65 mL per animal
Reactions Reported:
Lack of efficacy (endoparasite) - heartworm
Outcomes: Ongoing

Dog, ['Great Pyrenees', 'Retriever - Labrador'], Female, 31.661 kilogram • Drug: MSK, Powder, Intramuscular, Dose: 3.17 mL per animal • Reactions: Vomiting • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075148
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Weight: 31.661 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Powder
  • Dose: 3.17 mL per animal
Reactions Reported:
Vomiting
Outcomes: Ongoing

Dog, ['Hound - Basset', 'Dog (unknown)'], Female, 4 year, 18.597 kilogram • Drug: MSK, Powder, Intramuscular, Dose: 1.80 mL per animal • Reactions: Injection site lump, Not himself/herself, Discomfort NOS, Weight loss • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075149
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 4.00 Year
  • Weight: 18.597 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Powder
  • Dose: 1.80 mL per animal
Reactions Reported:
Injection site lump Not himself/herself Discomfort NOS Weight loss
Outcomes: Ongoing

Dog, Bulldog - French, Male, 2 year, 19.051 kilogram • Drug: MSK, Powder, Intramuscular • Reactions: Injection site swelling • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075147
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 2.00 Year
  • Weight: 19.051 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Powder
Reactions Reported:
Injection site swelling
Outcomes: Ongoing

Dog, Terrier - Bull - American Pit, Female, 4 year, 40.098 kilogram • Drug: MSK, Powder, Intramuscular, Dose: 4 mL per animal • Reactions: Injection site swelling, Injection site warmth • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-073914
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 4.00 Year
  • Weight: 40.098 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Powder
  • Dose: 4 mL per animal
Reactions Reported:
Injection site swelling Injection site warmth
Outcomes: Ongoing

Dog, Terrier - Bull - Staffordshire, Female, 4 year, 30.935 kilogram • Drug: MSK, Powder, Intramuscular, Dose: 2.90 mL per animal • Reactions: Vomiting, Regurgitation, Nausea, Gastric distension, Medication error NOS… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-072505
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 4.00 Year
  • Weight: 30.935 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Powder
  • Dose: 2.90 mL per animal
Reactions Reported:
Vomiting Regurgitation Nausea Gastric distension Medication error NOS Abnormal radiograph finding
Outcomes: Ongoing

Dog, Terrier - Bull - American Pit, Male, 2 year, 29.03 kilogram • Drug: MSK, Powder, Intramuscular, Dose: 3.50 mL per animal • Reactions: Otitis externa, Trigeminus paralysis, Vomiting, Cough, Muscle atrophy… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-072504
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 2.00 Year
  • Weight: 29.030 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Powder
  • Dose: 3.50 mL per animal
Reactions Reported:
Otitis externa Trigeminus paralysis Vomiting Cough Muscle atrophy Elevated serum alkaline phosphatase Elevated alanine aminotransferase Drooling Unusual stool colour Erythema Elevated gamma-glutamyl transferase Elevated total bilirubin Abnormal ultrasound finding Hepatic fibrosis Hepatitis Tiredness (lethargy) Angioedema Generalised rash Trouble breathing (dyspnea) Increased lung sounds Leucocytosis NOS Icterus Abnormal radiograph finding Jaw disorder
Outcomes: Ongoing

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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