Medicine Information

Alphanate

Name: Alphanate
Brand: Alphanate
Rating: 4.5 (117 reviews)

Powder and solvent for solution for injection250 IUHemostatics; Blood Coagulating FactorsATC: B02BD02

Generic Name

Antihemophilic Factor/von Willebrand Factor Complex (Human)

Manufacturer

Takeda (formerly Baxter)

Country

United States, Europe

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
alphanate 250 iu injection	৳ 9,900.00	N/A

Description

Overview of the medicine

Alphanate 250 IU Injection is a sterile, lyophilized powder containing human Antihemophilic Factor (Factor VIII) and von Willebrand Factor (vWF) for intravenous administration. It is derived from human plasma and undergoes multiple viral inactivation steps.

Uses & Indications

Treatment and prophylaxis of bleeding in patients with Hemophilia A (congenital Factor VIII deficiency).

Treatment of spontaneous or trauma-induced bleeding episodes in patients with von Willebrand disease (vWD) where desmopressin is either ineffective or contraindicated.

Perioperative management for patients with Hemophilia A or vWD requiring surgical intervention.

Dosage

Adults

Dosage is individualized based on Factor VIII and vWF levels, patient's weight, severity of bleeding, and clinical response. For Hemophilia A, calculate dose (IU) = body weight (kg) x desired FVIII increase (%) x 0.5. For vWD, dosage varies greatly; often 50-80 IU vWF:RCo/kg for initial treatment of bleeding.

Elderly

No specific dosage adjustment required; however, caution should be exercised due to potential age-related comorbidities.

Renal_impairment

No specific dosage adjustment guidelines. Monitor for fluid overload and adverse reactions.

How to Take

For intravenous infusion only. Reconstitute the lyophilized powder with the supplied sterile water for injection according to manufacturer's instructions. Administer slowly (e.g., 2-4 mL/minute) at a rate comfortable for the patient. Do not mix with other medicinal products.

Mechanism of Action

Alphanate provides exogenous Factor VIII (FVIII) and von Willebrand Factor (vWF). FVIII is an essential cofactor for Factor IXa in the intrinsic coagulation cascade, leading to the formation of thrombin and fibrin. vWF acts as a carrier protein for FVIII, protecting it from degradation, and also mediates platelet adhesion and aggregation to the damaged vessel wall, which is crucial for primary hemostasis.

Pharmacokinetics

Onset

Immediate upon intravenous administration.

Excretion

Metabolized into small peptides and amino acids; excreted via renal and fecal routes.

Half life

Factor VIII: Approximately 8-12 hours. von Willebrand Factor: Approximately 12-24 hours.

Absorption

Administered intravenously, hence 100% bioavailability.

Metabolism

Endogenous Factor VIII and vWF are cleared from circulation, primarily by proteolysis. Exogenous factors follow similar metabolic pathways.

Side Effects

Contraindications

Hypersensitivity to the active substance or to any of the excipients.
Known allergic reactions to human plasma-derived proteins.

Drug Interactions

No specific drug interactions have been reported.

However, it is always advisable to inform your doctor about all medications you are taking, including over-the-counter drugs and herbal supplements.

Storage

Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. May be stored at room temperature (up to 25°C / 77°F) for a single period not exceeding 3 months.

Overdose

Symptoms of overdose are unlikely with Alphanate 250 IU Injection due to its specific use and individualized dosing. High doses may lead to hypervolemia, which could manifest as cardiovascular strain or allergic reactions. Management involves discontinuation of the infusion and symptomatic treatment.

Pregnancy & Lactation

Use during pregnancy and lactation only if clearly indicated and the potential benefits outweigh the potential risks to the fetus/infant. Consult a physician before use.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

Single vial with diluent and administration set.

Shelf Life

Typically 2-3 years when stored as recommended. Refer to the specific product packaging for exact expiry date.

Availability

Available in hospitals and specialized pharmacies globally.

Approval Status

Approved in many countries (e.g., US, EU)

Patent Status

Patent expired for original formulation, may have patents for specific manufacturing processes or new indications.

WHO Essential Medicine

Yes

Clinical Trials

Alphanate has undergone extensive clinical trials demonstrating its efficacy and safety in treating Hemophilia A and von Willebrand disease. Studies typically focus on pharmacokinetic parameters, inhibitor development rates, and control of bleeding episodes.

Lab Monitoring

Regular monitoring of Factor VIII activity levels is essential to ensure adequate hemostatic levels.
Monitor for the development of Factor VIII inhibitors using Bethesda assay at regular intervals.
Periodic screening for blood-borne viruses (e.g., HIV, HBV, HCV) is recommended, although the product is highly purified and virally inactivated.

Doctor Notes

Emphasize the importance of patient education regarding signs of inhibitor development and hypersensitivity reactions.
Individualize dosing based on patient's Factor VIII/vWF levels and clinical needs.
Ensure proper cold chain maintenance during storage and transport.

Patient Guidelines

Always follow your doctor's instructions regarding dose, frequency, and administration technique.
Report any signs of allergic reactions (e.g., rash, hives, difficulty breathing) immediately.
Do not change your dose or stop treatment without consulting your healthcare provider.
Be aware of the signs of inhibitor development (e.g., treatment failure, increased bleeding).

Missed Dose Advice

If a scheduled prophylactic dose is missed, administer it as soon as possible. Do not double the next dose. Consult your physician for specific guidance.

Driving Precautions

Alphanate 250 IU Injection is not known to affect the ability to drive or operate machinery. However, if you experience side effects like dizziness or headache, avoid such activities.

Lifestyle Advice

Maintain good oral hygiene to prevent dental bleeding.
Avoid contact sports and activities that carry a high risk of injury.
Carry your medical ID identifying you as a hemophiliac patient or vWD patient.

Alternative Medicines in Bangladesh

Similar medicines available in the market

There might be other Factor VIII or vWF concentrates available. Consult local distributors or physicians for specific brand availability in Bangladesh.