Immiticide
Name: Immiticide
- Immiticide drug
- Immiticide injection
- Immiticide dosage
- Immiticide mg
- Immiticide weight loss
- Immiticide 50 mg
Caution
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
WARNINGImmiticide® 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. (See SAFETY)
Indications
Immiticide Sterile Powder is indicated for the treatment of stabilized Class 11, 22, and 33 heartworm disease caused by immature (4 month-old, stage L5) to mature adult infections of Dirofilaria immitis in dogs.
Heartworm Disease Classification
The following parameters were used to classify the dogs in the clinical field trials for Immiticide. Other parameters may be considered. As a general rule, conservative treatment should be employed since heartworm disease is serious and potentially fatal. If there is evidence of a high worm burden, patients should be categorized as Class 3.
1 Class 1: Patients in this category are characterized as having asymptomatic to mild heartworm disease. No radiographic signs or signs of anemia are evident. Patients with mild disease may have subjective signs such as a general loss of condition, fatigue on exercise, or occasional cough; however, no objective radiographic or other abnormal laboratory parameters will be present. 2 Class 2: Patients in this category are characterized as having moderate heartworm disease. Radiographic signs or signs of anemia [Packed Cell Volume (PCV) less than 30% but greater than 20%, or other hematologic parameters below normal] are evident. Mild proteinuria (2+) may be present. Radiographic signs may include right ventricular enlargement, slight pulmonary artery enlargement, or circumscribed perivascular densities plus mixed alveolar/interstitial lesions. Patients may be free of subjective clinical signs or may have a general loss of condition, fatigue on exercise, or occasional cough. If necessary, patients should be stabilized prior to treatment. 3 Class 3: Patients in this category are characterized as having severe heartworm disease. These patients have a guarded prognosis. Subjective signs of disease may include cardiac cachexia (wasting), constant fatigue, persistent cough, dyspnea, or other signs associated with right heart failure such as ascites and/or jugular pulse. Radiographic signs may include right ventricular enlargement or right ventricular plus right atrial enlargement, severe pulmonary artery enlargement, circumscribed to chronic mixed patterns and diffuse patterns of pulmonary densities or radiographic signs of thromboembolism. Signs of significant anemia (PCV <20% or other hematologic abnormalities) may be present. Proteinuria (> 2+) may be present. Patients may have only moderate clinical signs and significant laboratory or radiographic alterations or they may have significant clinical signs with only moderate laboratory and radiographic signs and be categorized as Class 3. Patients in Class 3 should be stabilized prior to treatment and then administered the alternate dosing regime (See PRECAUTIONS and DOSAGE AND ADMINISTRATION).Contraindications
Immiticide is contraindicated in dogs with very severe (Class 4) heartworm disease. Patients in this category have Caval Syndrome (D. immitis present in the venae cavae and right atrium).
Warnings
(See boxed Warning.) For use in dogs only. Safety for use in breeding animals and lactating or pregnant bitches has not been determined.
ADVERSE REACTIONS (Side Effects)
Injection Sites: At the recommended dosage in clinical field trials, significant irritation was observed at the intramuscular injection sites, accompanied by pain, swelling, tenderness, and reluctance to move. Approximately 30% of treated dogs experienced some kind of reaction at the injection site(s). Though injection site reactions were generally mild to moderate in severity and recovery occurred in 1 week to 1 month, severe reactions did occur (< 1.0 %), so care should be taken to avoid superficial or subcutaneous injection and leakage. Firm nodules can persist indefinitely.
Other Reactions
Coughing/gagging, depression/lethargy, anorexia/inappetence, fever, lung congestion, and vomiting were the most common reactions observed in dogs treated with Immiticide. Hypersalivation and panting occurred rarely in clinical trials (1.9% and 1.6%, respectively); however, these signs may occur within 30 minutes of injection and may be severe. One dog vomited after each injection of Immiticide, despite pretreatment with anti-emetics. All adverse reactions resolved with time or treatment with the exception of a limited number of injection site reactions (persistent nodules, (See Table: Average Onset Time and Duration (with Ranges) of the Most Common Reactions in Clinical Trials) and a low number of post-treatment deaths (See Mortality).
Prevalence of Clinical Observations/Adverse Reactions Reported in Clinical Field Trials
The following table enumerates adverse events that occurred in 1.5% or more of dogs with Class 1, 2, and 3 heartworm disease treated with Immiticide in clinical field trials. Comparison is made with the same adverse events reported in dogs treated with placebo. Some of the following clinical observations/adverse reactions seen in dogs treated with Immiticide may be directly attributable to the drug or they may be secondary to worm death and/or the underlying heartworm disease process.
| Clinical Observation/Adverse Reaction | Immiticide % of dogs n=311 | PLACEBO % of dogs n=63 |
|---|---|---|
| Injection Site Reactions | 32.8 | 3.2 |
| Coughing/Gagging | 22.2 | 14.3 |
| Depression/Lethargy | 15.4 | 4.8 |
| Anorixia/Inappetence | 13.2 | 3.2 |
| Pyrexia (fever) | 7.4 | 0.0 |
| Lung Congestion/Sounds | 5.5 | 1.6 |
| Emesis | 5.1 | 1.6 |
| Diarrhea | 2.6 | 0.0 |
| Dyspnea | 2.6 | 1.6 |
| Hypersalivation | 1.9 | 0.0 |
| Panting | 1.6 | 0.0 |
| Hemoptysis | 1.6 | 0.0 |
Clinical observations/adverse reactions occurring in less than 1.5% of the dogs treated with Immiticide include: abdominal hemorrhage, abdominal pain, bloody stool/diarrhea, colitis, gingivitis, pancreatitis, anemia, DIC, hemoglobinemia, icterus (mucous membranes), discolored urine, hematuria, inappropriate urination, low specific gravity, polyuria, pyuria, bronchitis, miscellaneous respiratory problem, pneumonia, tachypnea, tracheobronchitis, wheezing, alopecia, hair color and coat character change, miscellaneous skin problem, ataxia, disorientation, fatigue/tires easily, miscellaneous eye problem, weight loss, convulsion/seizure, leukocytosis, polydipsia, and restlessness.
Onset and Duration of Clinical Observations/Adverse ReactionsThe following table is provided to show the average onset time post-treatment for the most common reactions and the average duration of each event, as calculated from the 311 dogs treated with Immiticide in the clinical field trials.
| Clinical Observation/Adverse Reaction | Ave. Onset Time in Days (range)* | Ave. Duration in Days (range)* | |
|---|---|---|---|
| * A zero indicates that the reaction first occurred on the day of treatment. | |||
| Injection Site | |||
| Swelling/Edema/Seroma | 6 (0*-77) | 18 (<1-210) | |
| Pain/Discomfort/Irritation/Inflammation/Heat | 1 (0-6) | 3 (<1-30) | |
| Generalized/Local Myalgia with Tenderness and Stiffness | 3 (1-8) | 9 (<1-30) | |
| Persistent (lumps, knots, nodules, masses) | 22 (0-99) | 47 (1-152) | |
| Abscess (sterile and septic) | 24 (10-42) | 21 (5-36) | |
| Coughing/Gagging | 10 (0-103) | 13 (<1-134) | |
| Depression/Lethargy | 5 (0-46) | 6 (<1-48) | |
| Anorexia/Inappetence | 5 (0-63) | 5 (<1-30) | |
Mortality
Death is a possible sequelae of heartworm disease in dogs with or without treatment, especially in the Class 3 dogs. The following table shows the percentage of dogs that died in clinical trials with Immiticide® and the causes of death, if known.
| CLASS 1, 2 % OF DOGS n=267 | CLASS 3 % OF DOGS n=44 | ||
|---|---|---|---|
| Total Deaths Cause: | 5.2 | 18.2 | |
| Trauma | 2.3 | 2.3 | |
| Thromboembolism | 0.0 | 4.6 | |
| Euthanasia (unrelated to treatment or underlying disease | 1.1 | 0.0 | |
| Euthanasia (related to treatment or underlying disease | 0.0 | 2.3 | |
| Underlying Disease | 0.8 | 2.3 | |
| Undetermined | 1.1 | 6.8 |
In one small (n=15), uncontrolled field study in severely ill (Class 3) dogs, 5 dogs died following treatment. Pulmonary thromboembolism was the cause of one death. The remaining dogs were not necropsied. All 5 dogs were in right heart failure at the time of treatment. Clinical signs seen in this study which were not seen in the larger studies include atrial fibrillation, collapse, hypothermia, and weakness.
Post Approval Experience
In addition to the aforementioned adverse reactions reported in pre-approval clinical studies, there have also been rare reports of paresis and paralysis in dogs following administration of Immiticide. To report a suspected adverse reaction, contact Merial at 1-888-637-4251, option 3.
Overdosage
Three dogs were inadvertently overdosed with Immiticide in the clinical field trials when the dose was calculated on a mg/lb basis rather than a mg/kg basis (2X overdosage). Within 30 minutes of injection, one dog showed excessive salivation, panting, restlessness, and fever with all signs resolving within 4 hours. Vomiting and diarrhea were seen in the second dog within 24 hours of injection. The dog vomited once and the diarrhea resolved within 24 hours. The third dog showed no systemic reaction to the overdosage. Clinical observations in healthy beagle dogs after receiving up to 3X the recommended dose included tremors, lethargy, unsteadiness/ataxia, restlessness, panting, shallow and labored respiration, rales, severe salivation, and vomiting which progressed to respiratory distress, collapse, cyanosis, stupor, and death (See SAFETY).
BAL in Oil Ampules (Dimercaprol Injection, USP) [Akorn, San Clemente, California, at 1-800-223-9851] is reported in the literature to be an antidote for arsenic toxicity and was shown in one study to reduce the signs of toxicity associated with overdosage of Immiticide. The efficacy of Immiticide may be reduced with co-administration of BAL.
PRINCIPAL DISPLAY PANEL - 50 mg Vial Kit
Immiticide®
Sterile Powder
Canine Heartworm Treatment
ACTIVE INGREDIENT: melarsomine dihydrochloride 5 x 50 mg vials
DILUENT for RECONSTITUTION: sterile water for injection USP 5 x 2 ml vials
CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
NADA 141-042, Approved by FDA
MERIAL
| Immiticide melarsomine dihydrochloride and water kit | ||||||||||||||
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| Labeler - Merial Limited (034393582) |