Brand Names:

• Orencia

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Immune Modulator

Uses of This Medicine:

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, this medicine does not cure arthritis and will help you only as long as you continue to take it.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

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.

Older adults—

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—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Other medicines—

Using this medicine 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 this medicine 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

Other interactions—

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infections—This medicine should NOT be started in patients who have active infections of any type. This medicine 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 This Medicine:

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

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits to make sure that this medicine 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).

This medicine 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.

This medicine 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 this medicine may increase your chance of having serious side effects.

Side Effects of This Medicine:

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:

More common

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

Less common

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

Rare

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:

More common

Acid or sour stomach

belching

heartburn

indigestion

stomach discomfort or upset

Less common

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.