INTRODUCTION OF DARBECON 40MCG
DARBECON 40MCG 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 DARBECON 40MCG 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.
DARBECON 40MCG PREFILLED SYRINGE(PFS) is not recommended for use in patients having high blood pressure which is not being controlled. Before receiving DARBECON 40MCG 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.
DARBECON 40MCG PREFILLED SYRINGE(PFS) should be used with caution in pregnant women. Patients must not breastfeed while receiving DARBECON 40MCG PREFILLED SYRINGE(PFS). No data is available regarding DARBECON 40MCG PREFILLED SYRINGE(PFS) use in children (less than 1 month old) with CKD receiving and not receiving dialysis. The safety and efficacy of DARBECON 40MCG 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 DARBECON 40MCG 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 DARBECON 40MCG
Treats symptomatic anemia
- Associated with chronic renal failure (CRF) in adults and children
- With non-myeloid malignancies receiving chemotherapy in adult cancer patients
HOW DARBECON 40MCG PREFILLED SYRINGE(PFS) WORKS
DARBECON 40MCG 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
DARBECON 40MCG 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 DARBECON 40MCG PREFILLED SYRINGE(PFS) unless your doctor advises you to stop.
SIDE EFFECTS OF DARBECON 40MCG PREFILLED SYRINGE(PFS)
COMMON
- High blood pressure
- Allergic reactions
- Stroke
- Pain around the area of injection
- Rash or redness of the skin
- Blood clots
- Fluid retention (swelling)
UNCOMMON
- Convulsions (fits and seizures)
- Bruising and bleeding at the site of injection
- Blood clots in a dialysis access
RARE
Stop receiving DARBECON 40MCG PREFILLED SYRINGE(PFS) and contact your doctor immediately if you experience any of the following side effects:
- Serious skin rashes like Stevens-Johnson syndrome and toxic epidermal necrolysis (reddish macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and fever or flu-like symptoms)
- Severe headache, drowsiness, confusion, eyesight problem, nausea, vomiting or fits (could imply very high blood pressure)
- Lack of energy and tiredness (pure red cell aplasia (PRCA)), which means that the body has stopped or reduced the production of red blood cells which causes severe anemia
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
PREGNANCY
DARBECON 40MCG PREFILLED SYRINGE(PFS) should be used with caution in pregnant women. If you are pregnant, think you may be pregnant or are planning for a baby, consult your doctor before receiving it.
BREASTFEEDING
DARBECON 40MCG PREFILLED SYRINGE(PFS) is not recommended for use in breastfeeding women because it is not known if it is excreted in breast milk. Consult your doctor before receiving it.
DRIVING AND USING MACHINES
DARBECON 40MCG PREFILLED SYRINGE(PFS) should not affect the ability to drive or use machines.
KIDNEY
In patients with chronic kidney failure, your doctor will adjust the correct dose and duration of DARBECON 40MCG PREFILLED SYRINGE(PFS) treatment depending on your age, body weight and disease condition. Consult your doctor before receiving DARBECON 40MCG PREFILLED SYRINGE(PFS).
LIVER
DARBECON 40MCG PREFILLED SYRINGE(PFS) should be used with caution in patients with liver disease and hepatitis C. Consult your doctor before receiving DARBECON 40MCG PREFILLED SYRINGE(PFS).
ALLERGY
Before receiving DARBECON 40MCG PREFILLED SYRINGE(PFS) inform your doctor if you are allergic to Darbepoetin alfa or any of the other ingredients of this medicine or latex (Ex. needle cap on the pre-filled syringe).
HEART DISEASE
DARBECON 40MCG PREFILLED SYRINGE(PFS) is not recommended for use in patients with high blood pressure which is not being controlled with other medicines. DARBECON 40MCG PREFILLED SYRINGE(PFS) should be used with caution in patients with high blood pressure which is being controlled. Consult your doctor before receiving DARBECON 40MCG PREFILLED SYRINGE(PFS).
OTHERS
Before receiving DARBECON 40MCG PREFILLED SYRINGE(PFS), inform your doctor if you have:
- Sickle cell anemia
- Epileptic fits (seizures)
- Convulsions
- Lack of response to certain medicines used to treat anemia
Use in pediatrics:
No data is available regarding DARBECON 40MCG PREFILLED SYRINGE(PFS) use in children (less than 1-month-old) with CKD receiving and not receiving dialysis. The safety and efficacy of DARBECON 40MCG PREFILLED SYRINGE(PFS) in children with cancer have not been established so, consult your child’s doctor for advice.
Use in geriatrics:
No differences in safety or efficacy have been observed between older and younger patients. Consult your doctor before receiving DARBECON 40MCG PREFILLED SYRINGE(PFS).
INTERACTIONS
A. Drug-Drug interactions:
Before receiving DARBECON 40MCG 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:
DARBECON 40MCG 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.
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