Alphanate Iv Infusion, Injection, Solution, Intravenous Powder For Injection

Antihemophilic Factor/ Von Willebrand Factor Complex (Human) contains Antihemophilic Factor (FVIII) and von Willebrand Factor (VWF), constituents of normal plasma, which are required for clotting. The administration of Alphanate temporarily increases the plasma level of FVIII, thus minimizing the hazard of hemorrhage in patients with hemophilia A. FVIII is an essential cofactor in activation of factor X leading to formation of thrombin and fibrin. VWF promotes platelet aggregation and platelet adhesion on damaged vascular endothelium; it also serves as a stabilizing carrier protein for the procoagulant protein FVIII.

Uses

Alphanate, (antihemophilic factor/von Willebrand factor complex), is used for:

  • Control and prevention of bleeding episodes and perioperative management in adult and pediatric patients with Factor VIII(FVIII) deficiency due to hemophilia A.
  • Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand Disease (VWD) in whom desmopressin (DDAVP) is either ineffective or contraused. It is not used for patients with severe VWD (Type 3) undergoing major surgery.
Trade Name Alphanate
Generic Alphanate
Weight 250iu/vial, 250iu, , +
Type Iv Infusion, Injection, Solution, Intravenous Powder For Injection
Therapeutic Class Haemostatics
Manufacturer Grifols Biologicals Inc, Usa, Instituto Grifols
Available Country Bangladesh, Saudi Arabia, United States, Netherlands,
Last Updated: June 23, 2021 at 11:16 am

Dosage

Alphanate dosage

Alphanate contains the labeled amount of Factor VIII expressed in International Units (IU) FVIII/vial and Willebrand. 

Factor: Ristocetin Cofactor activity in IU VWF:RCo/vial.

Hemophilia A: Control and prevention of bleeding episodes

  • Dose (units) = body weight (kg) x desired FVIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)
  • Frequency of intravenous injection of the reconstituted product is determined by the type of bleeding episode and the recommendation of the treating physician

Von Willebrand Disease: Surgical and/or invasive procedure in adult and pediatric patients except Type 3 undergoing major surgery

  • Adults: Pre-operative dose of 60 IU VWF:RCo/kg body weight; subsequent doses of 40-60 IU VWF:RCo/kg/body weight at 8-12 hour intervals post-operative as clinically needed.
  • Pediatric: Pre-operative dose of 75 IU VWF:RCo/kg/body weight; subsequent doses of 50-75 IU VWF:RCo/kg body weight at 8-12 hour intervals post-operative as clinically needed.
  • Dosage based on protocol used in the Alphanate prospective clinical trial according to judgment of the investigator.

Pediatric Use-

  • Hemophilia A Indication: Clinical trials for safety and effectiveness in pediatric hemophilia A patients 16 years of age and younger have not been conducted.
  • VWD Indication: The hemostatic efficacy of Alphanate has been studied in 20 pediatric subjects with VWD 18 years of age and under. Based on the data from a subset of these subjects, age had no effect on the pharmacokinetics of VWF:RCo. There were no clinically important differences between pediatric patients and adults.

Geriatric Use: No human or animal data. Use only if clearly needed.

Alphanate is for intravenous use only after reconstitution. Use plastic disposable syringes. Do not refrigerate after reconstitution. Reconstituted Alphanate may be stored at room temperature (not to exceed 30° C) prior to administration, but administer intravenously within three hours.

Discard any unused contents into the appropriate safety container. Do not administer Alphanate at a rate exceeding 10 mL/minute.

Side Effects

The most frequent adverse events reported with Alphanate in >5% of patients are respiratory distress, pruritus, rash, urticaria, face edema, paresthesia, pain, fever, chills, joint pain and fatigue

Precaution

Risk of thromboembolic events & infections. Pregnancy.

Pregnancy & Breastfeeding use

Pregnancy: No human or animal data. Use only if clearly needed 

Labor and Delivery: No human or animal data. Use only if clearly needed

Nursing Mothers: No human or animal data. Use only if clearly needed

Contraindication

Alphanate is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components.

Special Warning

Pediatric Use: Clinical trials for safety and effectiveness in pediatric hemophilia A patients have not been conducted. The hemostatic efficacy of Alphanate has been studied in 20 pediatric subjects with VWD 18 years of age and under. Based on the data from a subset of these subjects, age had no effect on the pharmacokinetics of VWF:RCo

Geriatric Use: No human or animal data. Use only if clearly needed

FAQ

What are the side effects of Alphanate?

Common side effects are

  • drowsiness.
  • visible water retention.
  • headache.
  • nausea.
  • intense abdominal pain.
  • dizziness.

What is Alphanate used for?

Amlodipine and olmesartan is a combination of medicines that may be used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.

How long does Alphanate take to work?

Alphanate may take up to 2 weeks before you get the full benefit of this drug. Tell your doctor if your condition does not improve or if it worsens (your blood pressure readings remain high or increase).

Is Alphanate a good blood pressure medication?

Alphanate lowers your blood pressure and makes it easier for your heart to pump blood around your body. It's often used as an alternative treatment if you have had to stop taking a similar medicine because it gave you a dry, irritating cough.

When is the best time to take Alphanate?

It does not matter what time of day you take Alphanate (morning or evening) but it is best to take it at the same time every day, when you are most likely to remember, for more even blood levels and therefore effectiveness.

What happens when you stop taking Alphanate?

If you don't take Alphanate or stop taking it, your blood pressure or chest pain may get worse. This could lead to serious problems, such as a stroke or heart attack. If you skip or miss doses: If you skip or miss doses, your blood pressure or chest pain may get worse.

What type of drug is Alphanate?

Alphanate (amlodipine / olmesartan) is a combination of two medications that lower blood pressure. Amlodipine (a calcium channel blocker) and olmesartan (an angiotensin II receptor blocker) both relax blood vessels in your body. Blood vessels dilate (get wider) when they relax which lowers the blood pressure.

What foods should I avoid when taking Alphanate?

Do not eat or drink lots of grapefruit or grapefruit juice while you're taking Alphanate. Grapefruit can increase the concentration of amlodipine in your body and worsen side effects. If you're taking amlodipine as a liquid, it'll come with a plastic syringe or spoon to help you measure out the right dose.

Why is Alphanate given at night?

New research suggests that taking your blood pressure medication at bedtime may more effectively reduce your risk of illness or death due to heart and blood vessel disease. Timing of medication is important because blood pressure follows a daily rhythm. It rises higher during the day and falls at night when we sleep.

What is the best way to stop taking Alphanate?

Do not stop taking Alphanate suddenly. Although no "rebound" effect has been reported, it is better to slowly decrease the dosage over a period of time. Your doctor may advise you to take sublingual nitroglycerin for any break-through angina pain.

Do I have to take Alphanate forever?

Alphanate will not cure your high blood pressure, but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You might have to take high blood pressure medicine for the rest of your life.

How long does Alphanate stay in my body?

The average half-life of Xanax in the blood is 11.2 hours in healthy adults, meaning that half of the drug has been metabolized and eliminated in the urine in that time frame. It takes about five half-lives for 98% of a drug dose to clear the body, so Xanax takes 2–4 days to be fully eliminated from the body.

Is Alphanate a blood thinner?

Alphanate has a unique medical agent designed to block angiotensin II, a natural chemical in your body that can raise blood pressure by causing blood vessels to tighten and narrow. By blocking this chemical, Alphanate widens and relaxes blood vessels to help lower blood pressure.

Does Alphanate cause heart palpitations?

Common side effects of Alphanate include swelling, flushing, and palpitations (a pounding or racing heartbeat).