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GENEPLAT

RECOMBINANT HUMAN INTERLEUKIN-11 · by MEDINET

IMMUNOSTIMULANTS Recombinant human Interleukin, thrombopoietic growth factor MEDINET

Composition

Inj 1.5 mg/12MIU Recombinant human Interleukin 11, Sterile Lyophilized powder for injection

Indications & Dosage

Prevention of severe thrombocytopenia resulting from chemotherapy of solid tumors or non-myeloid leukemia, For reducing the need for platelet transfusion following myelosuppressive chemotherapy, Myelodysplastic syndrome, Interferon induced thrombocytopenia: BY SC INJ: Adults: 25-50 ?g/kg given once daily; course of treatment is generally 14-21 days.

Administration

Subcutaneous administration of rh-IL-11, 24-48 hours right after the course of chemotherapy is over or when the number of platelets is lower than normal. Dissolve 1 vial with 1ml sterilized water for injection. Rotate injection sites for each administration.

Stability

Store refrigerated between 2C-8C (36F-46F), syringes should be kept in their carton to protect from light until time of use. Before injection, may be allowed to reach room temperature for administration. Freezing should be avoided.

Contraindications

Hypersensitivity to E. coli derived substance. It should be used after chemotherapy, not recommended using before or in the course of chemotherapy, not indicated following myeloablative chemotherapy.

Precautions

Severe or decompensated heart failure; it may cause excessive fluid retention with edema and cardiac decompensation, organic heart disease, especially patients with congestive heart failure, atrial fibrillation/flutter, pediatric patients, renal impairment; monitor closely. Complete blood counts should be obtained before and during treatment, stop administration when platelet counts reaches normal limit. Patients should be watched for signs of allergy, fluid retention and anemia during and after therapy. Monitor the capillary vascular leakage syndrome, including weight, puffiness and serous cavity fluid etc. Preexisting ascites and pericardial effusions should be monitored closely for signs of worsening.

Pregnancy

Use only if the benefit to the mother outweighs the risk.

Lactation

Discontinue breast-feeding

Side Effects

Edema, headache, fever & neutropenic fever, increased heart rate, vasodilation and irregular heart rhythm, nausea, vomiting, GI fungal infections, dizziness, insomnia, shortness of breath, flu-like symptoms, cough, pharyngitis, pleural effusion, rash, paresthesia, dehydration, discoloration of skin, exfoliative dermatitis and hemorrhage from eye conjunctival congestion and transient blurred vision.