Rebinyn (intravenous)

Rebinyn (intravenous)

Used for Rebinyn

Factor IX is a protein that is produced naturally in the body. This medicine is an artificial protein made to replicate factor IX, which occurs naturally in the body. It is used to stop bleeding by helping blood clot in patients with hemophilia B.

This medicine should only be administered by or under the supervision of your doctor or other healthcare professional.

Before using Rebinyn

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

Related studies conducted to date have not demonstrated any pediatric-specific problems that would limit the benefit of glycoPEGylated coagulation factor IX (recombinant) injection in children.

geriatrics

Related studies conducted to date have not shown any geriatric-specific problems that would limit the benefit of glycoPEGylated coagulation factor IX (recombinant) injection in the elderly.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. Tell your doctor if you are taking other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. Discuss using your medicine with food, alcohol or tobacco with your doctor.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Allergie gegen Hamsterprotein – Sollte bei Patienten mit dieser Erkrankung nicht angewendet werden.

• Gerinnungsstörungen (einschließlich disseminierter intravasaler Gerinnung, Thrombose) oder
• Lebererkrankung – Mit Vorsicht anwenden. Diese Erkrankungen können das Risiko der Bildung von Blutgerinnseln erhöhen.

• Nephrotisches Syndrom (Nierenerkrankung) – Mit Vorsicht anwenden. Kann diesen Zustand verschlimmern.

• Patienten mit Faktor-IX-Hemmern: Möglicherweise erhöhtes Risiko einer allergischen Reaktion.

Proper use of Rebinyn

A doctor or other trained healthcare professional will give you this medicine. You may also be trained to administer this medicine yourself. This medicine is given through a needle into one of your veins.

This medicine comes with a package leaflet. Read and follow these instructions carefully. If you have any questions, contact your doctor or pharmacist.

Precautions when using Rebinyn

It is very important that your doctor monitor you closely while you or your child is receiving this medicine to make sure it is working properly. Blood and urine tests are required to check for adverse effects.

This medicine can cause serious allergic reactions, including anaphylaxis. This can be life-threatening and requires immediate medical attention. Tell your doctor immediately if you experience rash, itching, hoarseness, difficulty breathing, difficulty swallowing, or swelling of your hands, face, or mouth after taking this medication.

This medicine may increase your risk of blood clotting problems. Tell your doctor right away if you experience sudden or severe headache, vision or speech problems, chest pain, shortness of breath, or numbness or weakness while taking this medication.

This medicine can cause a serious kidney problem called nephrotic syndrome. Contact your doctor immediately if you have cloudy or bloody urine, high blood pressure, or swelling of your face, feet, or lower legs.

Call your doctor immediately if this medicine does not prevent or stop bleeding as expected.

Rebinyn side effects

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Contact your doctor or nurse immediately if any of the following side effects occur:

Less common

• Husten
• Schluckbeschwerden
• Schwindel
• schneller Herzschlag
• Nesselsucht, Juckreiz, Ausschlag
• Schwellungen oder Schwellungen der Augenlider oder um die Augen, das Gesicht, die Lippen oder die Zunge
• Engegefühl in der Brust
• ungewöhnliche Müdigkeit oder Schwäche

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

Less common

• Blutungen, Blasenbildung, Brennen, Kälte, Verfärbung der Haut, Druckgefühl, Nesselsucht, Infektion, Entzündung, Juckreiz, Knoten, Taubheitsgefühl, Schmerzen, Hautausschlag, Rötung, Narbenbildung, Schmerzen, Stechen, Schwellung, Empfindlichkeit, Kribbeln, Geschwüre oder Wärme an der Injektionsstelle

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand names

In the USA

• Rebinyn

Available dosage forms:

• Pulver zur Lösung

Therapeutic class: Antihemophilic agent

More information