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Roxee Medication Guide
Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
Veterinary professional?
These are the reference facts Roxee uses on browse cards and quick facts.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
Drug type: Generic ingredient • Generic profile • No FDA branded products linked
Species: Both
Manufacturer: Anzac Animal Health, LLC
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
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.
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 .
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): Lack of efficacy (endoparasite) - heartworm, INEFFECTIVE, HEARTWORM LARVAE, Vomiting, Weight gain, Other abnormal test result NOS, Lethargy (see also Central nervous system depression in 'Neurological').
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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:
When to call the vet:
Regulatory restrictions are shown in Vet View.
What to tell or ask your vet today:
A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.
Roxee has limited cited overview evidence for Melarsomine; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 26 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.
Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.
Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.
Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.
Vomiting (1 reports), Trouble breathing (dyspnea) (1 reports), Increased lung sounds (1 reports), Inappropriate defecation (1 reports), Icterus (1 reports)
Digestive (2), Skin & allergy (1), Neurologic (1), Behavior (2)
Dog (28 reports), Cat (4 reports)
Terrier - Bull - American Pit (2), Shepherd Dog - German (1), ['Terrier - Jack Russell', 'Dog (unknown)'] (1), ['Great Pyrenees', 'Retriever - Labrador'] (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Melarsomine fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.
Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.
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, 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
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Review status / Updated / Sources
Review status: Clinical reviewer not listed
Updated: April 15, 2026, 10:04 AM UTC
Side effects to monitor:
Most reported reactions:
Emergency warning signs:
Source-backed clinical checkpoints for quick review.
Official label facts first, then secondary summaries. Marketing content is separated below.
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.
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.
Received 2025-12-11 · MSK · MSK
Received 2025-12-04 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| 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 | Dog | 1 |
Species coverage: Dog (28) Cat (4)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Digestive | Dog | Serious | - | 1 | |
| Neurologic | Cat | Non-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 | 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 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Behavior | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Behavior | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 |
The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.
Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.
Full source previews and metadata remain in the veterinary/professional layer.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
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.
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.
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 · FOI
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
Quick facts and links to official labeling and safety signals.
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 54771-1920-1 | 54771 | - |
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
Every non-trivial field is expected to include provenance and update timestamps.
Official sponsor/proprietary-name/application-status records linked by active ingredient.
| Product | Sponsor | Application | Status | Published |
|---|---|---|---|---|
|
DIROBAN®
RX
Melarsomine Dihydrochloride
Powder
• Intramuscular
|
Anzac Animal Health, LLC | ANADA 200-609 | Approved | Jan 28, 2020 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
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.
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.
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
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
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.
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Showing top 5 for Digestive.
Showing top 5 for Skin & allergy.
Showing top 5 for Neurologic.
Showing top 5 for Behavior.
Showing top 5 for Other.
Data source: FDA openFDA Animal & Veterinary adverse event reports.
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
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
Dog, ['Great Pyrenees', 'Retriever - Labrador'], Female, 31.661 kilogram • Drug: MSK, Powder, Intramuscular, Dose: 3.17 mL per animal • Reactions: Vomiting • Outcome: 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
Dog, Bulldog - French, Male, 2 year, 19.051 kilogram • Drug: MSK, Powder, Intramuscular • Reactions: Injection site swelling • Outcome: 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
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
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
Data source: FDA openFDA Animal & Veterinary adverse event reports.
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.