Recombinate

What is Recombinate?

Recombinate is a prescription medicine that is used to treat hemophilia. It is used to treat or prevent bleeding.

Description

RECOMBINATE [Antihemophilic Factor (Recombinant)] is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture, the CHO cell line secretes recombinant Factor VIII (rFVIII) into the cell culture medium. The rFVIII is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monoclonal antibody directed to Factor VIII, is utilized to selectively isolate the rFVIII in the medium. The synthesized rFVIII produced by the CHO cells has the same biological effects as human Factor VIII. Structurally the protein has a similar combination of heterogenous heavy and light chains as found in human Factor VIII.

RECOMBINATE is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant Factor VIII for intravenous injection. RECOMBINATE is available in single-dose vials, which contain nominally 250, 500, 1000, 1500, and 2000 International Units per vial. When reconstituted with the appropriate volume of diluent, the product contains the following stabilizers in maximum amounts: For 5 mL reconstitution volume: 25 mg/mL Albumin (Human), 0.40 mg/mL calcium, 3 mg/mL polyethylene glycol (3350), 360 mEq/L sodium, 110 mM histidine, 1.5 µg/Factor VIII International Unit (IU) polysorbate-80. Recombinant Von Willebrand Factor (rVWF) is coexpressed with the rFVIII and helps to stabilize it. The final product contains not more than 2 ng rVWF/IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand’s disease. The product contains no preservative.

Each vial of RECOMBINATE is labeled with the Factor VIII activity expressed in IU per vial. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.

Before taking Recombinate, tell your doctor:

• If you are allergic to Recombinate; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are allergic to cows, hamsters, or mice.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Recombinate with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Recombinate?

• Tell all of your health care providers that you take Recombinate. This includes your doctors, nurses, pharmacists, and dentists.
• Allergic side effects may rarely happen.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Call the doctor right away if the normal dose does not work as well.
• Talk with the doctor before you travel. You will need to bring enough of Recombinate for use during travel.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Recombinate best taken?

Use Recombinate as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Wash your hands before and after use.
• If stored in a refrigerator, let Recombinate come to room temperature before mixing. Do not heat Recombinate.
• This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
• Do not shake.
• Most products will be clear and colorless after mixing. Some products may be clear to slightly cloudy and colorless after mixing. Some products may be colorless to a faint yellow after mixing. Be sure you know what the product will look like after mixing.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• After mixing, do not refrigerate.
• After mixing, be sure you know how long the product is good for and how to store it. Ask your doctor or pharmacist if you are not sure.
• Throw away any part of opened vial not used after use.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Recombinate that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like 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; or swelling of the mouth, face, lips, tongue, or throat.
• A burning, numbness, or tingling feeling that is not normal.
• Change in color of mouth to blue.
• Chest pain or pressure or a fast heartbeat.
• Dizziness or passing out.
• Feeling cold.
• Fever or chills.
• Flushing.
• Pale skin.
• Restlessness.
• Shortness of breath.
• Upset stomach or throwing up.

What are some other side effects of Recombinate?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where the shot is given.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Recombinate?

• If Recombinate is given at home, store unopened containers at room temperature or in the refrigerator. Do not freeze.
• Store in the original container to protect from light.
• If stored at a temperature higher than room temperature, talk with the doctor to see if Recombinate may still be used.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else’s drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Recombinate, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what
  

  was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Recombinate or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Recombinate. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Label

PRINCIPAL DISPLAY PANEL – 5 ML VIAL LABEL

• 5 mL
  NDC 52919-003-08
  Shire
• Sterile Water for Injection, USP
  for reconstitution of accompanying product
• Do not use unless clear. No antimicrobial agent or other substance
  has been added. Do not use for intravascular injection without making
  approximately isotonic by additon of suitable solute.
• Rx Only
• 0742003
• Single dose container
  Nonpyrogenic

PRINCIPAL DISPLAY PANEL – 10 ML VIAL LABEL – 250 IU

• NDC 0944-2831-01
• RECOMBINATE
• [Antihemophilic Factor (Recombinant)]
• For Intravenous Administration Only
• Store in refrigerator at 36° to 46°F (2° to 8°C)
  or Store at room temperature up to 86°F (30°C)
  After reconstitution do not refrigerate
• Contains no preservative
• Direction for Use: Read package insert
• Baxalta US Inc.
  Lexington, MA 02421 USA
  U.S. License No. 2020
• Rx Only

SRC: NLM .