HIGH DOSE HIGH EFICACY
ReciGen (interferon beta-1a)
Prefilled syringe, 44 mcg (12 Million IU) in 0.5 mL (0.5 cc)
What is ReciGen?
ReciGen (interferon beta-1a) is made from human proteins. Interferons help the body fight viral infections.
What is ReciGen used for?
ReciGen is used to treat relapsing multiple sclerosis (MS). This medication will not cure MS, it will only decrease the frequency of relapse symptoms.
ReciGen may also be used for purposes not listed in this medication guide.
What should I know BEFORE taking ReciGen?
You should not use ReciGen 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 ReciGen 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 ReciGen 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. ReciGen may cause harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
It is not known whether interferon beta-1a passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
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 ReciGen?
Use ReciGen 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.
ReciGen is injected under the skin. It is usually given 3 times per week (such as Monday, Wednesday, and Friday) at the same time on each dosing day. 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.
ReciGen 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 ReciGen 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.
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.
ReciGen 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 ReciGen in a refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze.
Throw away any ReciGen that has become frozen or has been exposed to light or high heat.
What should I know, while taking ReciGen?
Get emergency medical help if you have any of these signs of an allergic reaction to ReciGen: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Common ReciGen 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 ReciGen. There are no controlled data in human pregnancy. Seven women became pregnant during ReciGen clinical studies; 5 women delivered normal babies at full term and 2 women had spontaneous abortions. Among 32 pregnant patients treated with ReciGen 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 ReciGen recommends that caution be used when administering interferon beta-1a to nursing women.
How should I store ReciGen?
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.