EFALIZUMAB

Because efalizumab is an immunosuppressive agent, it has the potential to increase the risk of infection and reactivate latent, chronic infections.

Efalizumab should not be administered to patients with clinically significant infections.

You should check with your doctor immediately if any of these less common side effects occur when taking efalizumab:

• accumulation of pus
• chest pain
• cough
• cough producing mucus
• diarrhea
• difficulty in breathing or swallowing
• fast heartbeat
• fever or chills
• headache
• increased bone pain in vertebrae
• itching, pain, redness, swelling, tenderness, or warmth on the skin
• loss of appetite
• muscle or joint stiffness, tightness, or rigidity
• nausea
• pain or tenderness around the eyes and cheekbones
• rash or redness
• shortness of breath
• skin itching
• sneezing
• sore throat
• stiff neck or back
• stomach pain
• stuffy or runny nose
• swelling of the face, throat, or tongue
• swollen, red, or tender area of infection
• tightness in the chest
• vomiting
• weakness
• wheezing

Rare

• back pain
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• dark urine
• difficulty in moving
• general tiredness and weakness
• hearing loss
• light-colored stools
• muscle pain
• pain, swelling, or redness in the joints
• pinpoint, red spots on the skin
• small usually colored spots on the skin
• spots on your skin resembling a blister or pimple
• sudden and severe muscle weakness, sudden and progressing
• swollen salivary glands
• unusual bleeding or bruising
• unusual lumps or skin changes
• upper right abdominal pain
• yellow eyes and skin

Incidence not known

• back pain, sudden and severe
• blistering, peeling, or loosening of the skin
• blurred vision
• cold or flu-like symptoms
• confusion
• convulsions
• dizziness
• drowsiness
• general feeling of illness
• headache
• inability to move arms and legs
• increased sensitivity of the skin to sunlight
• lower back or side pain
• muscle weakness, sudden and progressing
• numbness, tingling, pain, or weakness in the hands or feet
• painful or difficult urination
• red skin lesions, often with a purple center
• red, irritated eyes
• redness or other discoloration of the skin
• severe sunburn
• skin rash
• sores, ulcers, or white spots in the mouth or on the lips
• sudden numbness and weakness in the arms and legs
• swollen glands
• unusual tiredness or weakness
• weakness of the muscles in your face
• weight loss

Some of the side effects that can occur with efalizumab may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common side effects:

• difficulty in moving
• general feeling of discomfort or illness
• joint pain
• loss of appetite
• muscle cramping
• shivering
• sweating
• swollen joints
• trouble sleeping

Less common

• blemishes on the skin
• lack or loss of strength
• pimples
• swelling of the hands, ankles, feet, or lower legs

Precautions

• Allergic reaction to this medication
• Increased risk of serious infections
• Patients with any active or chronic infection arthritis, or a weak immune system (caused by disease or by using certain medicines)
• You should be current on all immunizations before you start using efalizumab
• Increased risk of developing certain types of cancer
• Used only when clearly needed during pregnancy
• Consult your doctor before breast feeding

Consult your doctor regarding the precautions mentioned above.

Interactions

Dexamethasone, belatecept or bexxar may interact with this drug.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including;

• alcohol
• antihistamines (such as cetirizine, diphenhydramine)
• drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem)
• muscle relaxants
• narcotic pain relievers (such as codeine)

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Overdose

Initial Dose: 0.7 mg/kg subcutaneously once.

Maintenance Dose: 1 mg/kg subcutaneously weekly.

A maximum single dosage has been imposed at 200 mg as recommended by the manufacturer.

The safety and efficacy of efalizumab therapy beyond one year have not been established.

Brands

There are no brands containing this molecule.