Diroban 25mg/mL
Diroban (melarsomine dihydrochloride) 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) to mature adult infections of Dirofilaria immitis in dogs. See package insert for complete product details.
ACTIVE INGREDIENT
DIROBAN Sterile Powder for Injection contains 50.0 mg melarsomine dihydrochloride and 33.75 mg glycine USP.
1 vial: when reconstituted with the provided 2 mL of STERILE DILUENT (sterile water for injection) contains 25 mg/mL of active ingredient.
INDICATIONS
DIROBAN Sterile Powder for Injection is indicated for the treatment of stabilized Class 1a, 2b, and 3c heartworm disease caused by immature (4 month-old, stage L5) to mature adult infections of Dirofilaria immitis in dogs.
CONTRAINDICATIONS
DIROBAN 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.
HUMAN WARNINGS
Keep this and all medications out of the reach of children. Avoid human exposure. Wash hands thoroughly after use or wear gloves. Potentially irritating to eyes. Rinse eyes with copious amounts of water if exposed. Consult a physician in cases of accidental exposure by any route (dermal, oral, or by injection).
PRECAUTIONS
General: All dogs with heartworm disease are at risk for post-treatment pulmonary thromboembolism (death of worms which may result in fever, weakness, and coughing), though dogs with severe pulmonary arterial disease have an increased risk and may exhibit more severe signs (dyspnea, hemoptysis, right heart failure and possibly death). Dogs should be restricted from light to heavy exercise post-treatment depending on the severity of their heartworm disease.
Studies in healthy (heartworm negative) dogs indicate that adverse reactions may occur after the second injection in the series even if no problems were encountered with the first injection. All patients should be closely monitored during treatment and for up to 24 hours after the last injection.
Special Considerations for Class 3 dogs: Following stabilization, severely ill (Class 3) dogs should be treated according to the alternate dosing regime in an attempt to decrease post-treatment mortality associated with thromboembolism (see DOSAGE AND ADMINISTRATION). Post-treatment mortality due to thromboembolism and/or progression of the underlying disease may occur in 10 to 20% of the Class 3 patients treated with DIROBAN (see Mortality). Hospitalization post-treatment and strict exercise restriction are recommended. Other supportive therapies should be considered on a case-by-case basis.
If the alternate dosing regime is used, expect increased injection site reactions on the side receiving the second injection since the skeletal muscles at the first injection site may not have fully recovered (healed). If persistent swelling is present at 1 month, the second injections may be delayed for several weeks up to 1 month.
Special Considerations for Older Dogs: In clinical field trials, dogs 8 years or older experienced more post-treatment depression/lethargy, anorexia/inappetence, and vomiting than younger dogs.
SAFETY
Melarsomine dihydrochloride has a low margin of safety. A single dose of 7.5 mg/kg (3X the recommended dose) can result in pulmonary inflammation, edema, and death. Daily administration of 2X and 3X the recommended dose for 6 days caused no renal injury; however, daily administration of these doses for 14 days caused renal damage in healthy dogs. Adverse reactions, primarily at the injection sites, were seen at the recommended dose in clinical trials (see ADVERSE REACTIONS).
Treatment Response: A baseline can be established pre-treatment by using commercially available in-office heartworm antigen test kits prior to treatment. Treatment response can be assessed best by heartworm antigen testing applied 4 months after treatment. A successful treatment is determined to be conversion from an antigen positive to an antigen negative status. In dogs with signs of heartworm disease, gradual improvement should be observed as the long-term effects of the heartworm infection resolve. Some dogs may have chronic effects that will not totally resolve.
CONCOMITANT THERAPY
During the course of clinical field trials, DIROBAN was administered concurrently with anti-inflammatories, antibiotics, insecticides, heartworm prophylactics, and various other drugs commonly used to stabilize and support dogs with heartworm disease with no adverse drug interactions noted.
Routine Prophylaxis: If the dog is not currently receiving commercially available heartworm preventatives, they may be administered consistent with label recommendations and re-exposure risk.
STORAGE CONDITIONS
Store upright at controlled room temperature (20� - 25�C). After reconstitution, solutions should be stored under refrigeration and kept from light in the original packaging for 36 hours. Do not freeze reconstituted solution.
No antimicrobial or other substance has been added to the sterile water diluent.
HOW SUPPLIED
DIROBAN is provided as: 5 - 50 mg vials of lyophilized melarsomine dihydrochloride with accompanying 5 - 2 mL vials of sterile water for injection.
ANADA 200-609, Approved by FDA
