abatacept (Intravenous route)

Commonly used brand name(s):

In the U.S.

• Orencia

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Immune Modulator

Uses For abatacept

Abatacept is used to treat symptoms of moderate-to-severe rheumatoid arthritis, such as joint pain, swelling, and stiffness, in adult patients who have not been helped by other medicines. It may also be used to treat symptoms of moderate-to-severe juvenile idiopathic arthritis in children 6 years of age and older. Abatacept helps improve the physical functioning of the patient and slow the progression of damage to the body from arthritis. However, abatacept does not cure arthritis and will help you only as long as you continue to take it.

abatacept is available only with your doctor's prescription.

Before Using abatacept

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For abatacept, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to abatacept or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of abatacept in children below 6 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of abatacept in the elderly. However, specific side effects may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of abatacept. Abatacept causes more serious infections and malignancies in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using abatacept with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adalimumab
• Anakinra
• Etanercept
• Golimumab
• Infliximab

Using abatacept with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bacillus of Calmette and Guerin Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of abatacept. Make sure you tell your doctor if you have any other medical problems, especially:

• Infections—abatacept should NOT be started in patients who have active infections of any type. abatacept may need to be stopped if you develop an infection.

• Tuberculosis—Patients with this condition should be treated first before taking abatacept.

• Breathing problems (such as chronic obstructive pulmonary disease [COPD] attack)—Abatacept may make the condition worse.

Proper Use of abatacept

A nurse or other trained health professional will give you abatacept. Abatacept is given through a needle that is placed in one of your veins.

Precautions While Using abatacept

It is important that your doctor check your progress at regular visits to make sure that abatacept is working properly and to check for unwanted effects.

Your body's ability to fight infection may be reduced while you are being treated with abatacept. It is very important that you call your doctor at the first signs of any infection (e.g., if you get a fever or chills).

abatacept may cause a serious allergic reaction. Check with your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you get the injection.

While you are being treated with abatacept, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given for 3 months before or while receiving abatacept.

abatacept contains maltose (a type of sugar) which may affect blood sugar levels. If you have diabetes and you notice a change in the results of your blood sugar tests or if you have any questions, check with your doctor. Your doctor may need you to use a different test for your blood sugar levels.

Do not take other medicines for arthritis unless you talk to your doctor. This includes adalimumab (Humira®), anakinra (Kineret®), etanercept (Enbrel®), infliximab (Remicade®), or rituximab (Rituxan®). Using any of these together with abatacept may increase your chance of having serious side effects.

abatacept Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Back pain
• bladder pain
• bloody or cloudy urine
• body aches or pain
• chills
• cough
• cough producing mucus
• difficult or labored breathing
• difficult, burning, or painful urination
• dizziness
• ear congestion
• fever
• flu
• frequent urge to urinate
• headache
• loss of voice
• lower back or side pain
• nasal congestion
• nausea or vomiting
• noisy breathing
• pain or tenderness around eyes and cheekbones
• shortness of breath or troubled breathing
• sneezing
• sore throat
• stuffy or runny nose
• tightness of chest or wheezing
• unusual tiredness or weakness

• Blurred vision
• burning or stinging of skin
• chest pain
• nervousness
• painful cold sores or blisters on lips, nose, eyes, or genitals
• pounding in the ears
• skin rash
• slow or fast heartbeat

• Abdominal pain or tenderness
• confusion
• difficulty in swallowing
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• flushing
• hives or welts
• itching, pain, redness, swelling, tenderness, or warmth on skin
• stomach pain
• sweating
• swelling of face, throat, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• heartburn
• indigestion
• stomach discomfort or upset

• Pain in arms or legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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