ReciGen (Interferon beta-1a) for Multiple Sclerosis

ReciGen (interferon beta-1a) is made from human proteins and helps the body fight viral infections.

ReciGen is used to treat relapsing multiple sclerosis (MS) and will help to decrease the frequency of relapse symptoms.

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

Tell your doctor if you have:

• liver disease;
• epilepsy or other seizure disorder;
• heart disease, chest pain (angina);
• a history of blood clots or bleeding disorder;
• a thyroid disorder; or
• a history of depression or suicidal behavior.
• are pregnant or planning to become pregnant. ReciGen may be harmful to your unborn baby.
• are breastfeeding or planning to breastfeed. It is not known whether ReciGen can pass into your breast milk.

ReciGen is injected under the skin. It is usually given 3 times per week at the same time on each dosing day. Follow your doctor’s instructions.

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

• liver problems: liver disease may happen when using ReciGen. Treatment should be stopped immediately if jaundice or symptoms of hepatic dysfunction occur. Use caution in patients with hepatic impairment or in those who abuse alcohol.

• Low blood count: leukopenia, Pancytopenia (rare), and thrombocytopenia have been reported. Your doctor will monitor your blood count levels at 1, 3, and 6 months post-therapy initiation and periodically thereafter.

• Flu-like symptoms: Flu-like symptoms may occur while taking ReciGen.

• Psychological problems: Interferons have been associated with psychiatric adverse events (psychosis, depression, suicidal behavior/ideation) in patients with and without previous psychiatric symptoms; use with caution in patients with depression.

• Seizures: some patients have had seizures while taking interferon, including patients who have never had seizures.

• Allergic reactions including anaphylaxis: may occur when using ReciGen.

• Infections: may happen when using ReciGen.

• Thyroid disorders: may occur with the use of CinnoVex and may worsen pre-existing thyroid conditions. Your doctor will monitor your thyroid function every 6 months.

• Autoimmune disorders: including hyper- and hypothyroidism, idiopathic thrombocytopenia, and rarely autoimmune hepatitis have been reported. Consider discontinuation of treatment if a patient develops a new autoimmune disorder while using ReciGen.

• Injection site reactions: severe injection site reactions have occurred, including pain, edema, erythema, cellulitis, abscess, and necrosis.  

• interferon beta-1a may either cause reversible direct myocardial toxicity or exacerbate underlying myocardial dysfunction.

• Cases of thrombotic microangiopathy manifesting as a hemolytic uremic syndrome (HUS) or thrombotic thrombocytopenic purpura (TTP) or (some fatal) have been reported.

• fever, chills, body aches, chest pain, flu symptoms;

• pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• severe pain, swelling, bruising, redness, oozing, or skin changes where the injection was given;

• changes in your vision;

• seizure (convulsions);

• feeling hot or cold, unexplained weight changes;

• kidney problems – swelling or rapid weight gain, blood in your urine, little or no urination;

• signs of a serious blood cell disorder – confusion, stomach pain, bloody diarrhea, feeling tired or irritable, vomiting;

• liver problems – nausea, dark urine, clay-colored stools, jaundice, upper stomach pain, itching, tired feeling, loss of appetite;

• or severe skin reaction – fever, sore throat, burning in your eyes, skin pain, swelling in your face or tongue, followed by a red or purple skin rash that spreads and causes blistering and peeling.

Store ReciGen in a refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze.