Aranesp 60mcg/0.3ml Singleject Syr

Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) that stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. It interacts with the erythropoietin receptor on progenitor cells in the bone marrow to stimulate red blood cell production. Darbepoetin alfa has a longer half-life than epoetin alfa due to its increased glycosylation, which results in a longer circulating half-life and allows for less frequent dosing.

Urgent Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Fast heartbeat
Shortness of breath
Sudden weight gain or swelling in the arms or legs
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Feeling confused
Cool or pale arm or leg
Difficulty walking
Dizziness or passing out
Excessive sweating
Seizures
Feeling extremely tired or weak
Pale skin

If you experience any of the following symptoms, which may indicate a blood clot, seek medical help immediately:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, change of color, or pain in a leg or arm
Trouble speaking or swallowing

In rare cases, a severe skin reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis may occur, which can cause serious health problems and even death. Seek medical help right away if you notice:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Stomach pain
Cough

This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you have high blood pressure, as this may affect your treatment.
If you have been diagnosed with Pure Red Cell Aplasia (PRCA), a specific type of anemia.
If you have cancer, as this may impact your treatment plan. Discuss your cancer diagnosis with your doctor to determine the best course of action.

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you are experiencing. Your doctor and pharmacist need this information to assess potential interactions and ensure your safety. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are scheduled to undergo surgery, consult with your doctor, as you may require an alternative medication to prevent blood clots while taking this drug.

Regular blood pressure monitoring is crucial, as this medication can cause high blood pressure. Adhere to your doctor's instructions for blood pressure checks. Additionally, follow your doctor's recommendations for blood work and discuss any concerns or questions with your doctor.

If you have a latex allergy, notify your doctor to ensure necessary precautions are taken. It is vital to take this medication only as directed by your doctor, as exceeding the prescribed dose can increase the risk of severe side effects. If you accidentally take more than the prescribed amount, contact your doctor immediately.

This medication increases red blood cell production in the blood. Be aware that misuse or abuse of this type of medication can lead to severe health complications, including stroke, heart attack, and blood clots. If you have any questions or concerns, consult with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.

• Signs and symptoms of cardiovascular events (chest pain, shortness of breath, weakness, numbness, vision changes)
• Signs and symptoms of thrombotic events (pain, swelling, redness in a limb; sudden shortness of breath; chest pain)
• Signs and symptoms of allergic reactions (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
• Signs and symptoms of pure red cell aplasia (sudden worsening of anemia, fatigue, pallor)
• Signs and symptoms of tumor progression (for cancer patients)
• Headache, seizures (especially with rapid rise in Hb or hypertension)

Category C. There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects.

It is not known whether darbepoetin alfa is excreted in human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Aranesp and any potential adverse effects on the breastfed infant from Aranesp or from the underlying maternal condition. The molecular weight is high, suggesting limited transfer into milk, but caution is advised.

Safety and efficacy have been established in pediatric patients (1 month to 16 years) with CKD. Dosing is weight-based. Safety and efficacy in pediatric patients with chemotherapy-induced anemia have not been established.

No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

• Darbepoetin alfa has a longer half-life than epoetin alfa, allowing for less frequent dosing (e.g., weekly, bi-weekly, or tri-weekly).
• Always ensure adequate iron stores (TSAT >20%, ferritin >100 ng/mL for CKD) before and during darbepoetin alfa therapy, as iron deficiency is the most common cause of ESA hyporesponsiveness.
• Strictly adhere to hemoglobin targets (10-11 g/dL) and avoid exceeding 11 g/dL due to increased risks of serious cardiovascular events and mortality.
• Monitor blood pressure closely, as hypertension is a common side effect and may require aggressive management.
• For cancer patients, Aranesp is not indicated for those receiving myelosuppressive chemotherapy when the anticipated outcome is cure, and should be discontinued when chemotherapy is completed.
• Patients should be educated on the signs and symptoms of serious adverse events, particularly cardiovascular and thrombotic events, and instructed to seek immediate medical attention if they occur.

• Epoetin alfa (Epogen, Procrit, Retacrit, etc.) - another ESA with shorter half-life.
• Methoxy polyethylene glycol-epoetin beta (Mircera) - another long-acting ESA.
• Iron supplementation (oral or intravenous) - essential for effective erythropoiesis.
• Red blood cell transfusions - for acute, severe anemia, but associated with risks.
• Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) like Roxadustat (Evrenzo) - newer class for CKD anemia (not yet widely available in all regions).

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call the poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.