Gammarec®

Patient Information

Gammarec^® is part of a drug regimen used to treat Chronic Granulomatous Disease, or CGD. CGD is a genetic disorder, usually diagnosed in childhood, that affects some cells of the immune system and the body’s ability to fight infections effectively. CGD is often treated (though not cured) with antibiotics, antifungals, and Gammarec^®.

What Gammarec^® is used for:

• Gammarec^® is used to reduce the frequency and severity of serious infections due to chronic granulomatous disease (CGD), a disorder that runs in families. This drug is often used along with antibiotics to help prevent these serious infections.
• Gammarec^® is also used to slow the worsening of malignant osteopetrosis, another disorder that runs in families, that affects bones, nerves, and blood.
• Gammarec^® is the same as a protein that your body naturally produces (interferon). In the body, it is thought to work by affecting cell function/growth and the body's natural defenses (immune system) in many ways. Adding more interferon may help your body fight off serious infections.

Tell your doctor or pharmacist before using Gammarec^® if :

• You are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex found in the packaging), which can cause allergic reactions or other problems.
• You have heart disease (such as angina, irregular heartbeat, congestive heart failure), liver disease, seizure disorder, blood cell disorders (such as anemia, neutropenia, thrombocytopenia).

Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist.

Who should not take Gammarec^®:

Don’t use Gammarec^® if you are allergic to interferon-gamma, E coli-derived products,

or any ingredients contained in the product.

How to take your Gammarec^®:

• Gammarec^® is given by injection under the skin as directed by your doctor, usually 3 times weekly (for example, Monday, Wednesday, and Friday).
• Gammarec^® is best used in the evening before bedtime to reduce side effects. If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional.
• Do not shake the Gammarec^®. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.
• It is important to change the location of the injection site with each dose to avoid problem areas under the skin. Choose a different injection site with each dose. The thighs and upper arms are recommended sites for the injection. Optimum sites are right and left deltoid, anterior thigh.
• Do not inject into skin that is irritated, sore, or infected.
• The dosage is based on your body size, medical condition, and response to treatment. Do not change the dose or how often you use this medication without your doctor's approval.
• Use Gammarec^®regularly to get the most benefit from it.
• To help you remember, use it at the same time each evening that you have a scheduled dose.

What to do if you forget to take a dose :

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

While taking your medicine :

• This drug may make you tired or cause mental changes. Alcohol or marijuana (cannabis) can make you more tired or cause mental changes.
• Do not drive, use machinery, or do anything that needs alertness until you can do it safely.
• Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
• Tell your health care professional that you are using this product before having any immunizations/vaccinations.
• Before having surgery, tell your doctor or dentist about all the products you use
• Children, especially those younger than 1 year, may be at greater risk for effects on the liver while using this drug.
• During pregnancy, this medication should be used only when clearly needed.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

What to do if you have Overdosed :

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call emergency center. Otherwise, call a poison control center right away.

Side effects :

The most common side effects with Gammarec^® are flu-like symptoms, such as fever, headache, chills, muscle pain, or fatigue, which may decrease in severity as treatment continues. Bedtime

administration of Gammarec^® may help minimize some of these symptoms. Acetaminophen may be helpful in preventing fever and headache.

If severe reactions occur, reduce dose by 50 percent or discontinue therapy until the adverse reaction abates

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed here.

You can also report side effects directly via the Yellow Card Scheme at: www.dorsapharma.com/ (ADR form)

By reporting side effects, you can help provide more information on the safety of this medicine.