For moderate to severe rheumatoid arthritis (RA)

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Indication/Usage

Adult Rheumatoid Arthritis (RA):
ORENCIA® (abatacept) is a prescription medicine that reduces signs and symptoms in adults with moderate to severe RA, including those who have not been helped enough by other medicines for RA. ORENCIA may prevent further damage to your bones and joints and may help your ability to perform daily activities. In adults, ORENCIA may be used alone or with other RA treatments other than tumor necrosis factor (TNF) antagonists.

Juvenile Idiopathic Arthritis (JIA): ORENCIA reduces signs and symptoms in patients 2 years of age and older with moderate to severe polyarticular JIA. ORENCIA may be used alone or with methotrexate (MTX).

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For Healthcare Professionals

Juvenile Idiopathic Arthritis (JIA) Clinical Trials With ORENCIA® (abatacept)

ORENCIA IV: for patients with moderate to severe polyarticular JIA

A clinical study of ORENCIA for intravenous (IV) infusion was conducted with 190 children and adolescents aged 6 to 17 years who had moderate to severe JIA, including the following subtypes:

  • Oligoarticular (involving a few joints)
  • Polyarticular (involving many joints)
  • Systemic with polyarticular course (with organ involvement, but not at time of study)

The study included patients who were new to biologics (70%) and patients who previously had an inadequate response to biologics, such as Enbrel® (etanercept) or Humira® (adalimumab).

The Results

  • In this clinical trial, ORENCIA was shown to improve physical function, and to help with daily activities as measured by the Childhood Health Assessment Questionaire.
  • ORENCIA demonstrated consistent improvement in signs and symptoms across the three JIA subtypes.

    Your child's results may vary.

Side effects seen in the clinical study

  • The most common infections were upper respiratory tract infection and nasopharyngitis*
  • Other events that occurred in at least 5% of patients were headache, nausea, diarrhea, cough, fever, and abdominal pain
  • Six serious adverse events occurred during the first 4 months of treatment (acute lymphocytic leukemia, ovarian cyst, Varicella infection, disease flare [2 cases], and joint wear)

*Nasopharyngitis: Inflammation of the nose and throat (characterized by sneezing, stuffy nose, cough, sore throat).

ORENCIA IV Study and Impact on Flares

For 4 months, all patients were given ORENCIA IV. After that period, 122 patients who had reduced signs and symptoms were divided into 2 groups. One group continued treatment with ORENCIA, and the other group did not.

For the next 6 months, doctors assessed both groups of patients to see which had worsening signs and symptoms of JIA. In other words, they checked for flares.

The risk of disease flares among patients continuing on ORENCIA was less than one-third than that of patients who had stopped treatment with ORENCIA.

Patients treated with ORENCIA IV had fewer flares compared to placebo-treated patients

Your child's results may vary.

Selected Important Safety Information

ORENCIA can cause serious side effects including:

Allergic reactions. Allergic reactions can happen to people who use ORENCIA. Call your healthcare provider or get emergency medical help right away if you have any symptoms of an allergic reaction, which may include hives; swollen face, eyelids, lips, or tongue; or trouble breathing.


ORENCIA SC Study and Impact on Flares

In a clinical trial, ORENCIA subcutaneous (SC) improved moderate to severe polyarticular JIA symptoms

ORENCIA SC injection was given to 205 patients, 2-17 years of age, with moderate to severe JIA, including the following subtypes:

  • Polyarticular (involving many joints)
  • Extended (involving a total of more than 4 joints after the first 6 months of disease) and Persistent (involving not more than 4 joints throughout the disease course) Oligoarticular
  • Enthesitis-Related Arthritis (swelling of the connective tissue where tendons or ligaments attach to bone)
  • Systemic with polyarticular course (with organ involvement, but not at time of study)

Treatment was given once weekly for 4 months and dosing was based on body weight.

Side effects for ORENCIA SC in the trial were consistent with the ORENCIA IV trial. There were no reported cases of hypersensitivity reactions. Local injection-site reactions occurred at a frequency of 4.4%.

Selected Important Safety Information

ORENCIA can cause serious side effects including:

Vaccinations. You should not receive ORENCIA with certain types of vaccines. ORENCIA may cause some vaccinations to be less effective.

How is ORENCIA given for JIA patients? You and your child have a choice

If your doctor determines that ORENCIA is the right treatment option for your child, the next step is to decide which option you and your child prefer for administration. ORENCIA can be given in 2 ways.

IV indicated for ages 6 and older

An ORENCIA IV (through a vein) infusion is given as a once-a-month procedure at the doctor’s office or infusion center and usually takes about 30 minutes. The infusion is given in your child’s arm. When the needle is placed, he or she may feel a pinch similar to a shot.

During the first month on ORENCIA, your child will receive a total of 3 doses. After the first dose on Day 1, the next doses will be around Days 15 and 29. Once the first 3 doses are complete, your child should receive ORENCIA every 4 weeks as directed by your child’s doctor.

ORENCIA IV has not been studied in children under the age of 6.

SC indicated for ages 2 and older

ORENCIA injection is a subcutaneous (under the skin) injection with a prefilled syringe. After initial training at the doctor’s office, you or your child can do this once-weekly injection yourself in the comfort of your own home.

Do not try to inject ORENCIA until you have been shown the right way by your rheumatologist or healthcare provider.

Your doctor will determine dosing based on your child’s weight.

How to inject ORENCIA for JIA

 

Selected Important Safety Information

ORENCIA can cause serious side effects including:

Allergic reactions. Allergic reactions can happen to people who use ORENCIA. Call your healthcare provider or get emergency medical help right away if you have any symptoms of an allergic reaction, which may include hives; swollen face, eyelids, lips, or tongue; or trouble breathing.

 

Selected Important Safety Information

ORENCIA can cause serious side effects including:

Important Safety Information

Serious infections. ORENCIA can make you more likely to get infections or make the infection that you have get worse. Some patients have died from these infections. Call your healthcare provider immediately if you feel sick or get any of the following signs of infection: fever; feel very tired; cough; feel flu-like; or warm, red or painful skin.

Allergic reactions. Allergic reactions can happen to people who use ORENCIA. Call your healthcare provider or get emergency medical help right away if you have any symptoms of an allergic reaction, which may include hives; swollen face, eyelids, lips, or tongue; or trouble breathing.

Vaccinations. You should not receive ORENCIA with certain types of vaccines. ORENCIA may cause some vaccinations to be less effective.

Hepatitis B infection. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use ORENCIA. Your healthcare provider may do a blood test before you start or while using ORENCIA.

Cancer (malignancies). Certain kinds of cancer have been reported in patients receiving ORENCIA. It is not known if ORENCIA increases your chance of getting certain kinds of cancer.

Inform your healthcare provider of the following, before you receive treatment with ORENCIA® (abatacept):

Infections: If you have any kind of infection, even if it is small (such as an open cut or sore), an infection that is in your whole body (such as the flu), an infection that will not go away, or a history of infections that keep coming back. ORENCIA may make your immune system less able to fight infections, so you may be more likely to get infections or any infection you have may get worse.

Tuberculosis: If you have had tuberculosis (TB), a positive skin test for TB, or if you recently have been in close contact with someone who has had TB. If you get any of the symptoms of TB (a cough that does not go away, weight loss, fever, night sweats), call your healthcare provider right away. Before you start ORENCIA, your healthcare provider may examine you for TB or perform a skin test.

If you have or have had Viral Hepatitis. Before you use ORENCIA, your healthcare provider may examine you for hepatitis.

If you have a history of Chronic Obstructive Pulmonary (lung) Disease (COPD).

If you are scheduled to have Surgery.

Allergies to the Ingredients of ORENCIA: The ingredients of intravenous (IV) ORENCIA are: abatacept, maltose, monobasic sodium phosphate, and sodium chloride for administration. The ingredients of subcutaneous (SC) ORENCIA are: abatacept, sucrose, poloxamer 188, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, and water for injection.

Vaccinations: If you have recently received a vaccination or are scheduled for any vaccination. If you are receiving ORENCIA, and for 3 months after you stop receiving ORENCIA, you should not take live vaccines.

Diabetes: If you have diabetes and use a blood glucose monitor to check your sugar levels. The infusion of ORENCIA contains maltose, a sugar that can give falsely high blood glucose readings with some monitors on the day you receive your infusion. Your healthcare provider may tell you to use a different way to monitor your blood sugar levels. ORENCIA for SC injection does not contain maltose; therefore, you do not need to change the way you monitor your blood sugar if you are taking ORENCIA subcutaneously.

Pregnancy: If you are pregnant, or plan to become pregnant. It is not known if ORENCIA can harm your unborn baby. If you took ORENCIA during pregnancy, talk to your healthcare provider before your baby receives any vaccines.

Breastfeeding: It is not known if ORENCIA passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you use ORENCIA.

If you Take Any Other Kinds of Medicine, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

If you are Taking Other Biologic Medicines to Treat RA or JIA such as: Enbrel® (etanercept), Humira® (adalimumab), Remicade® (infliximab), Kineret® (anakinra), Rituxan® (rituximab), Simponi® (golimumab), Cimzia® (certolizumab pegol), or Actemra® (tocilizumab). You may have a higher chance of getting a serious infection if you take ORENCIA with other biologic medicines.

Possible Side Effects of ORENCIA

ORENCIA can cause serious side effects including:

  • Serious infections. ORENCIA can make you more likely to get infections or make the infection that you have get worse. Some people have died from these infections. Call your healthcare provider immediately if you feel sick or get any of the following signs of infection: fever; feel very tired; cough; feel flu-like; or warm, red or painful skin.
  • Allergic reactions. Allergic reactions can happen to people who use ORENCIA. Call your healthcare provider or get emergency medical help right away if you have any symptoms of an allergic reaction, which may include hives; swollen face, eyelids, lips, or tongue; or trouble breathing.
  • Hepatitis B infection. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use ORENCIA. Your healthcare provider may do a blood test before you start treatment with ORENCIA.
  • Vaccinations. You should not receive ORENCIA with certain types of vaccines. ORENCIA may cause some vaccinations to be less effective.
  • Respiratory problems in people with COPD. You may get certain respiratory problems more often if you receive ORENCIA and have COPD, including: worsened COPD, cough, or trouble breathing.
  • Cancer (malignancies). Certain kinds of cancer have been reported in people receiving ORENCIA. It is not known if ORENCIA increases your chance of getting certain kinds of cancer.

Common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat, and nausea. Other side effects in children and adolescents may include diarrhea, cough, fever, and abdominal pain.

These are not all the possible side effects of ORENCIA.

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

There are three ways to receive your dose of ORENCIA, and each way is approved for different ages:

  • ORENCIA prefilled SC syringe is approved for patients 2 years and older
  • ORENCIA IV is approved for patients 6 years and older. ORENCIA IV has not been studied in children younger than 6 years of age.
  • ORENCIA ClickJect Autoinjector has not been studied in children under 18 years of age.

Please talk to your child’s healthcare provider about the best way for your child to receive ORENCIA.

Please click here to read the Patient Information in the Full Prescribing Information.

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JIA In-Office Caregivers Brochure (PDF).

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