Dargen 40 Injection

Dargen 40 Injection – Darbepoetin alfa 40 mcg/0.40 ml Pre-Filled Syringe by Lupin

Dargen 40 from Lupin is a single-dose pre-filled syringe containing Darbepoetin alfa (r-DNA origin) 40 mcg in 0.40 ml, used to treat the anaemia of chronic kidney disease and of chemotherapy. Darbepoetin is an engineered version of erythropoietin, the hormone the kidneys release to tell the bone marrow to make red blood cells – and in kidney failure the kidneys stop producing enough of it, which is why the anaemia develops in the first place. The engineering matters: darbepoetin carries two extra carbohydrate chains compared with natural erythropoietin, and that extra glycosylation slows its clearance so its half-life is roughly three times longer. In practice that means dosing once a week or once a fortnight instead of two or three times a week. The syringe carries a Preventis™ needle shield that locks over the needle with an audible click after injection. Cold-chain product – must be stored at 2°C to 8°C. Pack of 1 pre-filled syringe.

Key Features

• Darbepoetin alfa (r-DNA origin) 40 mcg per 0.40 ml single-dose pre-filled syringe
• Two extra carbohydrate chains give it about three times the half-life of erythropoietin
• Weekly or fortnightly dosing instead of two to three times a week
• Preventis™ safety needle shield – locks with an audible click after use
• For subcutaneous or intravenous use. Store at 2°C to 8°C. From Lupin Ltd.

Composition

• Darbepoetin alfa (r-DNA origin) – 40 mcg
• Monobasic Sodium Phosphate (Monohydrate) IP – 0.85 mg
• Sodium Phosphate Dibasic Anhydrous USP – 0.26 mg
• Sodium Chloride IP – 3.27 mg
• Polysorbate 80 IP – 0.020 mg
• Water for Injections IP – q.s. to 0.40 ml. As printed on the carton

Uses & Benefits

• Treats the anaemia of chronic kidney disease, in patients on dialysis and not on dialysis
• Treats anaemia caused by chemotherapy in certain cancers, as prescribed
• Reduces the need for red cell transfusions and the risks that come with them
• Longer-acting than erythropoietin, so far fewer injections for the same effect
• Single-dose pre-filled syringe – no vial, no drawing up, no dose calculation at the bedside
• Built-in safety shield reduces needlestick risk for whoever administers it

Directions for Use

• This is given by or under the direction of a doctor. It is injected under the skin or into a vein, and the route, dose and interval are set by your specialist from your haemoglobin and iron results
• Do not shake the syringe – shaking damages the protein and can make it inactive
• Take the syringe out of the fridge and let it reach room temperature naturally before injecting; do not warm it any other way
• Inspect it before use – do not use it if the liquid is cloudy, discoloured or contains particles
• After injecting, activate the Preventis™ shield by pushing the plunger rod firmly until it clicks, then dispose of the syringe in a sharps container immediately. Never reuse a syringe

Precautions

• Blood pressure must be controlled before and monitored during treatment. Raising the haemoglobin too fast or too high is the main hazard with this class and can cause severe hypertension and seizures
• Erythropoiesis-stimulating agents increase the risk of blood clots, stroke, heart attack and death when haemoglobin is pushed above the target range, and in cancer they may shorten survival or promote tumour progression in some settings. Your doctor uses the lowest dose that avoids transfusion
• Iron, vitamin B12 and folate must be adequate or this will not work. Iron stores are checked before and during treatment and iron is usually given alongside
• Tell your doctor about uncontrolled high blood pressure, a previous clot, epilepsy, liver disease, or pure red cell aplasia after any erythropoietin product
• Report severe headache, visual changes, confusion, seizures, chest pain, breathlessness, calf pain or swelling immediately
• Regular blood counts, blood pressure checks and iron studies are part of the treatment, not optional extras

Storage

• Store at 2°C to 8°C in a refrigerator. Do not freeze or shake. Protect from light, as printed on the carton
• Keep it in the outer carton until use, and never use a syringe that has been frozen
• Keep out of reach of children. For dosage, indication and administration refer to the package insert

Disclaimer

Schedule H prescription drug – to be sold by retail on the prescription of a Registered Medical Practitioner only. This is a biological medicine administered under specialist supervision, and it requires unbroken cold-chain storage at 2–8°C. This information is for general awareness and is not a substitute for professional medical advice, diagnosis or treatment.