DARBECURE 60 Prefilled Syringe(Pfs)

INTRODUCTION

DARBECURE 60 PREFILLED SYRINGE(PFS) contains Darbepoetin alfa which belongs to the group of medicines called Erythropoiesis-stimulating agents. It is used to treat symptomatic anemia associated with chronic renal failure (CRF) in adults and children. In kidney failure, the kidney does not produce enough erythropoietin (a natural hormone) which can often cause anemia. Before DARBECURE 60 PREFILLED SYRINGE(PFS) treatment, your doctor may want you to take blood tests to measure how your anaemia is responding and may adjust your dose to maintain long-term control of your condition. Your blood pressure will also be checked regularly, especially at the beginning of your treatment. DARBECURE 60 PREFILLED SYRINGE(PFS) is not recommended for use in patients having high blood pressure which is not being controlled. Before receiving DARBECURE 60 PREFILLED SYRINGE(PFS), inform your doctor if you have or ever had high blood pressure which is being controlled with medicines, sickle cell anemia, fits, liver disease, lack of response to medicines used to treat anemia, latex allergy or hepatitis C. DARBECURE 60 PREFILLED SYRINGE(PFS) should be used with caution in pregnant women. Patients must not breastfeed while receiving DARBECURE 60 PREFILLED SYRINGE(PFS). No data is available regarding DARBECURE 60 PREFILLED SYRINGE(PFS) use in children (less than 1 month old) with CKD receiving and not receiving dialysis. The safety and efficacy of DARBECURE 60 PREFILLED SYRINGE(PFS) in children with cancer have not been established so, consult your child’s doctor for advice. The most common side effects of receiving DARBECURE 60 PREFILLED SYRINGE(PFS) are high blood pressure, allergic reactions, pain around the area injected and rash or redness of the skin. Call your doctor if any of the symptoms worsen.

USES OF DARBECURE 60 PREFILLED SYRINGE(PFS)

Treats symptomatic anemia

• Associated with chronic renal failure (CRF) in adults and children
• With non-myeloid malignancies receiving chemotherapy in adult cancer patients

HOW DARBECURE 60 PREFILLED SYRINGE(PFS) WORKS

DARBECURE 60 PREFILLED SYRINGE(PFS) increases red blood cell counts by stimulating the bone marrow (soft tissue inside the bones where blood is made) to make more red blood cells.

DIRECTIONS FOR USE

DARBECURE 60 PREFILLED SYRINGE(PFS) will be given to you only by a doctor or a nurse either under your skin (subcutaneous) or into a vein (intravenous). Your doctor will decide on a proper dose and duration depending on your age, body weight and disease condition. Do not stop receiving DARBECURE 60 PREFILLED SYRINGE(PFS) unless your doctor advises you to stop.

SIDE EFFECTS OF DARBECURE 60 PREFILLED SYRINGE(PFS)

HOW TO MANAGE SIDE EFFECTS

Skin rash: Avoid hot showers as they can further irritate your skin. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. If the symptom persists, contact your doctor. Drowsiness: Try a few lifestyle changes to improve your energy levels when you feel drowsy such as taking and maintaining a consistent sleep schedule. Exercise regularly (such as a daily walk or running) and eat a nutritious diet with plenty of whole grains, legumes, fruits and vegetables. If the symptom persists, contact your doctor. Headache: Drink plenty of water and get adequate rest. Try to be relaxed and stress-free. Call your doctor before taking any medicine for headaches. If the headache persists, consult your doctor. Nausea: Take regular sips of a cold drink. Have ginger or peppermint tea. Stick to simple meals. Avoid eating oily or spicy foods. If the symptom persists, contact your doctor. Vomiting: Get adequate rest. Drink lots of fluids, especially water. Have small sips if you feel sick. Eat when you feel like it – no need to eat or avoid any specific foods. If the symptom persists, contact your doctor.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions: Before receiving DARBECURE 60 PREFILLED SYRINGE(PFS), inform your doctor if you are taking any of the following medicines:

• Cyclosporin and tacrolimus (used to suppress the immune system)

Overdosage:

DARBECURE 60 PREFILLED SYRINGE(PFS) will be administered to you only by a doctor or a nurse in a hospital, so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unusual symptoms like high blood pressure.