Rebinyn

What is Rebinyn used for?

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

Description

REBINYN is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution with the provided histidine diluent for intravenous infusion. After reconstitution, the solution appears as a clear and colorless liquid, free from visible particles and contains the following excipients per mL: sodium chloride, 2.34 mg; histidine, 3.10 mg; sucrose, 10 mg; mannitol, 25 mg; polysorbate 80, 0.05 mg. REBINYN is available in single-use vials containing the labeled amount of Factor IX activity, expressed in IU. Each vial contains nominally 500 IU, 1000 IU or 2000 IU. REBINYN potency is assigned using an in vitro, activated partial thromboplastin time (aPTT)-based, one-stage clotting assay calibrated against the World Health Organization (WHO) international standard for Factor IX concentrates. REBINYN contains no preservatives.

REBINYN is a purified recombinant human Factor IX (rFIX) with a 40 kilodalton (kDa) polyethylene-glycol (PEG) conjugated to the protein. The 40 kDa PEG group is selectively attached to specific -N-linked glycans in the rFIX activation peptide, with mono-PEGylated rFIX as the predominant form of REBINYN. The rFIX protein in REBINYN consists of a gamma-carboxylated (Gla) domain, two EGF-like (epidermal growth factor) domains, an activation peptide (which is cleaved off upon activation), and a protease domain. Once activated, the resulting rFIX has structural and functional properties similar to those of endogenous activated Factor IX. The primary amino acid sequence in REBINYN is identical to the Thr148 allelic form of human plasma-derived Factor IX and consists of 415 amino acids. The average molecular weight of REBINYN is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa. The nominal specific activity of REBINYN is 152 IU/mg protein.

REBINYN is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of REBINYN. The rFIX protein is purified by a series of chromatographic steps, including an affinity chromatography step using a monoclonal antibody (produced in CHO cells), to selectively isolate rFIX from the cell culture medium. The production process includes two dedicated viral clearance steps, namely a detergent treatment step for inactivation and a 20 nm filtration step for removal of viruses. The conjugation of the PEG-group is done by an enzymatic reaction during the purification process, followed by final purification of REBINYN.

Before taking Rebinyn, tell your doctor:

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

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 Rebinyn 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 Rebinyn?

• Tell all of your health care providers that you take Rebinyn. This includes your doctors, nurses, pharmacists, and dentists.
• Allergic side effects may rarely happen.
• Blood clots have happened with Rebinyn. Tell your doctor if you have ever had a blood clot. Talk with your doctor.
• 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 Rebinyn for use during travel.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Rebinyn while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Rebinyn best taken?

Use Rebinyn 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.
• This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
• If stored in a refrigerator, let Rebinyn come to room temperature before mixing. Do not heat Rebinyn.
• Do not shake.
• After mixing, you may store at room temperature for 4 hours. Store with the adapter and syringe on the vial.
• After mixing, do not refrigerate.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• 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 Rebinyn 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.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

What are some other side effects of Rebinyn?

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:

• Itching.
• Redness or swelling where the shot is given.
• Pain where the shot was given.

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 Rebinyn?

• Store in a refrigerator. Do not freeze.
• Store in original container.
• If needed, you may store at room temperature.
• If stored at room temperature, make a note of the date it was placed at room temperature.
• If stored at room temperature, throw away any unused vials after 6 months or after the expiration date, whichever comes first.
• Do not put Rebinyn back in the refrigerator after it has been stored at room temperature.
• 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.

 REBINYN Package

The instructions below serve as a general guideline for reconstitution of REBINYN. For full instructions, refer to the FDA-approved patient information and Instructions for Use.

Reconstitution

1. Bring the REBINYNvial and the pre-filled diluent syringe to room temperature.

2. Remove the plastic cap from the REBINYNvial.

3. Wipe the rubber stopperon the vial with a sterile alcohol swab and allow it to dry prior to use.

4. Remove the protective paper from the vial adapter. Do not remove the vial adapter from the protective cap.

5. Remove the protective paper from the vial adapter. Do not remove the vial adapter from the protective cap. Place the vial on a flat and solid surface. While holding the protective cap, place the vial adapter over the REBINYN vial and press down firmly on the protective cap until the vial adapter spike penetrates the rubber stopper.

6. Remove the protective cap from the vial adapter.

7. Grasp the plunger rod as shown in the diagram. Attach the plunger rod to the syringe by holding the plunger rod by the wide top end. Turn the plunger rod clockwise into the rubber plunger inside the prefilled diluent syringe until resistance is felt.

8. Break off the syringe cap from the pre-filled diluent syringe by snapping the perforation of the cap.

9. Connect the pre-filled diluent syringe to the vial adapter by turning it clockwise until it is secured.

10. Push the plunger rod to slowly inject all the diluent into the vial.

11. Without removing the syringe, gently swirl the REBINYN vial until all of the powder is dissolved.

12. Administer the REBINYN solution immediately [see ADMINISTRATION]. If not used immediately after reconstitution, store the solution in the vial with the vial adapter and the syringe attached, at room temperature ≥ 86°F (30°C). Do not store for longer than 4 hours.

SRC: NLM .