CinnoVex®


(interferon beta-1a)


CinnoVex (interferon beta-1a)

30 mcg Lyophilized Powder Vial

What is CinnoVex used for?

CinnoVex is used to treat relapsing multiple sclerosis (MS). This medication will not cure MS, it will only decrease the frequency of relapse symptoms.

CinnoVex may also be used for purposes not listed in this medication guide.

What should I know BEFORE taking CinnoVex?

You should not use CinnoVex if you are allergic to interferons or human albumin.

Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using CinnoVex if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.

To make sure CinnoVex is safe for you, tell your doctor if you have:

  • liver disease;
  • epilepsy or other seizure disorder;
  • heart disease, chest pain (angina);
  • a bleeding disorder or history of blood clots;
  • a thyroid disorder; or
  • a history of depression or suicidal behavior.

FDA pregnancy category C. CinnoVex may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Some brands of interferon beta-1a contain albumin. Albumin comes from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

What should I know BEFORE taking CinnoVex?

You should not use CinnoVex if you are allergic to interferons or human albumin.

Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using CinnoVex if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.

To make sure CinnoVex is safe for you, tell your doctor if you have:

  • liver disease;
  • epilepsy or other seizure disorder;
  • heart disease, chest pain (angina);
  • a bleeding disorder or history of blood clots;
  • a thyroid disorder; or
  • a history of depression or suicidal behavior.

FDA pregnancy category C. CinnoVex may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Some brands of interferon beta-1a contain albumin. Albumin comes from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How should I take CinnoVex?

Use CinnoVex exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

CinnoVex is injected into a muscle. It is usually given once weekly at bedtime, on the same day each week (such as every Monday). Follow your doctor's instructions.

You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

CinnoVex comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use a different place on your body each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

The powder form of CinnoVex must be mixed with a liquid (diluent) in the medicine vial. Gently swirl but do not shake the vial after mixing the medicine. The mixture should be clear or light yellow. Do not use the mixture if it has changed colors or has any particles in it. Mix a new dose or call your doctor for a new prescription.

Do not draw your dose into a syringe until you are ready to give yourself an injection.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left after injecting your dose.

Use a disposable needle only once, then throw away in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

CinnoVex can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Your liver or thyroid function may also need to be tested.

Store CinnoVex in a refrigerator. Do not freeze. Do not heat the medicine before using.

CinnoVex may be kept at room temperature for short periods if protected from light.

Throw away any CinnoVex that has become frozen or has been exposed to light or high heat.

What should I know BEFORE taking CinnoVex?

Avoid drinking alcohol. It may increase your risk of liver damage.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Get emergency medical help if you have any of these signs of an allergic reaction to CinnoVex: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common CinnoVex side effects may include:

  • stomach pain;
  • flu symptoms;
  • headache, drowsiness;
  • abnormal liver function tests; or
  • minor irritation where the injection was given.

This is not a complete list of side effects and others may occur.

Pregnancy and lactation

Animal studies have failed to reveal evidence of teratogenicity, but abortifacient activity has been demonstrated at higher than recommended doses of interferon beta. Non-dose-related increases in spontaneous abortions and fetal and neonatal deaths were observed in pregnant cynomolgus monkeys treated with daily intramuscular doses of interferon beta. There are no controlled data in human pregnancy. Seven women became pregnant during interferon beta clinical studies; 5 women delivered normal babies at full term and 2 women had spontaneous abortions. Among 32 pregnant patients treated with interferon beta who were followed in a pregnancy registry, 29 women had live births with no abnormalities at birth, 2 had spontaneous abortions, and 1 had a stillbirth. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: C Interferon beta-1a should be used during pregnancy only if the potential benefit outweighs the potential risk.

There are no data on the excretion of interferon beta-1a into human milk. The manufacturer of CinnoVex recommends that caution be used when administering interferon beta-1a to nursing women.

 

How should I store CinnoVex?

Store interferon beta-1a in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze.

Store away from heat, moisture, and light. Do not store in the bathroom. Keep interferon beta-1a, as well as needles and syringes, out of the reach of children and away from pets.

FAQs

A

Multiple sclerosis (MS) is a demyelinating disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged.[1] This damage disrupts the ability of parts of the nervous system to communicate, resulting in a range of signs and symptoms, including physical, mental, and sometimes psychiatric problems.[2][3][4] Specific symptoms can include double vision, blindness in one eye, muscle weakness, trouble with sensation, or trouble with coordination.[1] MS takes several forms, with new symptoms either occurring in isolated attacks (relapsing forms) or building up over time (progressive forms).[5] Between attacks, symptoms may disappear completely; however, permanent neurological problems often remain, especially as the disease advances.[5]

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