Orencia and Xeljanz Comparison

Orencia®(abatacept)	Xeljanz®(tofacitinib)
Prescription Only Orencia is a medication used to treat inflammatory conditions like rheumatoid arthritis and psoriatic arthritis. It suppresses the immune system and can be given through an IV...	Prescription Only Xeljanz is a medication that blocks a type of enzyme called Janus kinase (JAK) which helps to reduce inflammation in various conditions such as rheumatoid arthritis, psoriatic...
Administration
Intravenous Infusion or Subcutaneous Injection. Learn more.	Oral. Learn more.
Dosing
Intravenous: Administer at 0, 2, and 4 weeks, and every 4 weeks thereafter, as a 30-minute infusion (weight based). Subcutaneous: Administer 125 mg by subcutaneous injection once weekly (within a day of the intravenous infusion if infusion given).. Learn more.	XELJANZ 5 mg twice daily or XELJANZ XR 11 mg once daily. Severe renal impairment or moderate hepatic impairment is XELJANZ 5 mg once daily.. Learn more.
Latin Shorthand
intravenous: givethe medication at weeks 0, 2, and 4, and then every 4w thereafter, as a 30-minute infusion based on the patient's weight. Subcutaneous give 125 mg qw (within one day of the intravenous infusion if it was given). Learn more.	XELJANZ 5 mg twice daily or XELJANZ XR 11 mg once daily.. Learn more.
Out-Of-Pocket Costs With Copay Card
$5. Learn more.	$0. Learn more.
Annual Cap
$15,000. Learn more.	$25,000. Learn more.
Assistance Expiration
Every calendar year following activation. 13 uses per calendar year. . Learn more.	12/31/2023. Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Adverse Reactions
Most common adverse events (≥10%) in RA are headache, upper respiratory tract infection, nasopharyngitis, and nausea. Most common adverse reactions (≥10%) in prophylaxis of aGVHD are anemia, hypertension, CMV reactivation/CMV infection, pyrexia, pneumonia, epistaxis, CD4 lymphocytes decreased, hypermagnesemia, and acute kidney injury. . Learn more.	Most common adverse reactions are: Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis: Reported during the first 3 months in rheumatoid arthritis placebo-controlled clinical trials and occurring in ≥2% of patients treated with XELJANZ monotherapy or in combination with DMARDs: upper respiratory tract infection, nasopharyngitis, diarrhea, and headache. Ulcerative Colitis: Reported in ≥5% of patients treated with either 5 mg or 10 mg twice daily of XELJANZ and ≥1% greater than reported in patients receiving placebo in either the induction or maintenance clinical trials: nasopharyngitis, elevated cholesterol levels, headache, upper respiratory tract infection, increased blood creatine phosphokinase, rash, diarrhea, and herpes zoster. Polyarticular Course Juvenile Idiopathic Arthritis: Consistent with common adverse reactions reported in adult rheumatoid arthritis patients.. Learn more.
Mechanism of Actions (MoA)
Selective Immunosuppressants . Learn more.	Janus Kinase Inhibitors. Learn more.
Special Populations
Is there a pregnancy exposure registry for ORENCIA? Yes, there is a pregnancy exposure registry for ORENCIA that monitors pregnancy outcomes in women exposed to the drug during pregnancy. Healthcare professionals are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972. What is the risk associated with ORENCIA use during pregnancy? The data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. However, there are clinical considerations for administering live vaccines to infants who were exposed to ORENCIA while in utero (see Clinical Considerations). What are the clinical considerations for administering live vaccines to infants who were exposed to ORENCIA while in utero? It is unknown if abatacept, the active ingredient in ORENCIA, can cross the placenta into the fetus when a woman is treated with the drug during pregnancy. It is also unknown if the immune response of an infant who was exposed in utero to abatacept and subsequently administered a live vaccine is impacted. Risks and benefits should be considered prior to vaccinating such infants. Is ORENCIA safe to use during lactation? There is no information regarding the presence of abatacept, the active ingredient in ORENCIA, in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed with the drug. Is ORENCIA safe to use in pediatric patients? ORENCIA is safe and effective for reducing signs and symptoms in pediatric patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). Use of ORENCIA for this indication is supported by evidence from clinical studies. The safety and effectiveness of ORENCIA use in pJIA in pediatric patients less than two years of age have not been established. Can geriatric patients use ORENCIA for Rheumatoid Arthritis? Yes, geriatric patients (patients aged 65 years of age and older) can use ORENCIA for Rheumatoid Arthritis. Clinical studies involving 323 patients aged 65 years and older, including 53 patients aged 75 years and older, showed no overall differences in safety or effectiveness between geriatric patients and younger adults. However, caution should be used when treating geriatric patients due to the higher incidence of infections and malignancies in the geriatric population in general. The frequency of serious infection and malignancy among ORENCIA-treated patients over age 65 was higher than for those under age 65. Are there differences in response between geriatric patients and younger adult patients using ORENCIA for Rheumatoid Arthritis? Other reported clinical experience has not identified differences in responses between geriatric patients and younger adults when using ORENCIA for Rheumatoid Arthritis. However, greater sensitivity of some geriatric patients cannot be ruled out. Clinical studies of ORENCIA for acute graft versus host disease (aGVHD) did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.	Is there a pregnancy exposure registry for XELJANZ/XELJANZ XR/XELJANZ Oral Solution? Yes, there is a pregnancy exposure registry for XELJANZ/XELJANZ XR/XELJANZ Oral Solution that monitors pregnancy outcomes in women exposed to the drug during pregnancy. Patients should be encouraged to enroll in the registry if they become pregnant. To enroll or obtain information from the registry, patients can call the toll-free number 1-877-311-8972. What is the risk associated with XELJANZ/XELJANZ XR/XELJANZ Oral Solution use during pregnancy? Available data with XELJANZ/XELJANZ XR/XELJANZ Oral Solution use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. However, there are risks to the mother and the fetus associated with rheumatoid arthritis and UC in pregnancy. In animal reproduction studies, fetocidal and teratogenic effects were noted when pregnant rats and rabbits received tofacitinib during the period of organogenesis at exposures multiples of 73-times and 6.3-times the maximum recommended dose of 10 mg twice daily, respectively. Are there any clinical considerations related to XELJANZ/XELJANZ XR/XELJANZ Oral Solution use during pregnancy? Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis or ulcerative colitis. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. What is the estimated background risk of major birth defects and miscarriage for the indicated populations? The estimated background risks of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risks in the U.S. general population of major birth defects and miscarriages are 2 to 4% and 15 to 20% of clinically recognized pregnancies, respectively. Is it safe to breastfeed while taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution? No data is available on the presence of tofacitinib in human milk, the effects on a breastfed infant, or the effects on milk production. Tofacitinib is present in the milk of lactating rats. Given the serious adverse reactions seen in patients treated with XELJANZ/XELJANZ XR/XELJANZ Oral Solution, such as increased risk of serious infections, patients should be advised that breastfeeding is not recommended during treatment and for at least 18 hours after the last dose of XELJANZ/XELJANZ Oral Solution or 36 hours after the last dose of XELJANZ XR (approximately 6 elimination half-lives). Does XELJANZ/XELJANZ XR/XELJANZ Oral Solution affect female fertility? Based on findings in rats, treatment with XELJANZ/XELJANZ XR/XELJANZ Oral Solution may result in reduced fertility in females of reproductive potential. It is not known if this effect is reversible. Is XELJANZ/XELJANZ Oral Solution safe for use in pediatric patients? The safety and effectiveness of XELJANZ/XELJANZ Oral Solution have been established in patients 2 years to 17 years of age for the treatment of active pcJIA. The safety and efficacy of XELJANZ/XELJANZ Oral Solution in pediatric patients for indications other than pcJIA have not been established. The safety and effectiveness of XELJANZ XR in pediatric patients have not been established. What is the frequency of serious infection among XELJANZ-treated subjects who are 65 years and older? The frequency of serious infection among XELJANZ-treated subjects who are 65 years and older was higher than among those under the age of 65. How should caution be used when treating the elderly with XELJANZ? As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly with XELJANZ. Should caution be used when treating patients with diabetes with XELJANZ? Yes, caution should be used when treating patients with diabetes with XELJANZ as there is a higher incidence of infection in the diabetic population in general. Is dosage adjustment required in XELJANZ-treated patients with mild renal impairment? No, dosage adjustment is not required in XELJANZ-treated patients with mild renal impairment. Is XELJANZ recommended for use in patients with severe hepatic impairment? No, XELJANZ is not recommended for use in patients with severe hepatic impairment as it has not been studied in this population. Is dosage adjustment required in XELJANZ-treated patients with mild hepatic impairment? No, dosage adjustment is not required in XELJANZ-treated patients with mild hepatic impairment. Has the safety and efficacy of XELJANZ been studied in patients with positive hepatitis B or C virus serology? No, the safety and efficacy of XELJANZ have not been studied in patients with positive hepatitis B or C virus serology.

Orencia®(abatacept)

Xeljanz®(tofacitinib)

Prescription Only

Orencia is a medication used to treat inflammatory conditions like rheumatoid arthritis and psoriatic arthritis. It suppresses the immune system and can be given through an IV...

Prescription Only

Xeljanz is a medication that blocks a type of enzyme called Janus kinase (JAK) which helps to reduce inflammation in various conditions such as rheumatoid arthritis, psoriatic...

Dosage & Administration

Administration

Intravenous Infusion or Subcutaneous Injection. Learn more.

Oral. Learn more.

Dosing

Intravenous: Administer at 0, 2, and 4 weeks, and every 4 weeks thereafter, as a 30-minute infusion (weight based). Subcutaneous: Administer 125 mg by subcutaneous injection once weekly (within a day of the intravenous infusion if infusion given).. Learn more.

XELJANZ 5 mg twice daily or XELJANZ XR 11 mg once daily. Severe renal impairment or moderate hepatic impairment is XELJANZ 5 mg once daily.. Learn more.

Latin Shorthand

intravenous: givethe medication at weeks 0, 2, and 4, and then every 4w thereafter, as a 30-minute infusion based on the patient's weight. Subcutaneous give 125 mg qw (within one day of the intravenous infusion if it was given). Learn more.

XELJANZ 5 mg twice daily or XELJANZ XR 11 mg once daily.. Learn more.

Financial Assistance

Out-Of-Pocket Costs With Copay Card

$5. Learn more.

$0. Learn more.

Annual Cap

$15,000. Learn more.

$25,000. Learn more.

Assistance Expiration

Every calendar year following activation. 13 uses per calendar year. . Learn more.

12/31/2023. Learn more.

Generics

No lower-cost generic available

Physician Advisory

Adverse Reactions

Most common adverse events (≥10%) in RA are headache, upper respiratory tract infection, nasopharyngitis, and nausea. Most common adverse reactions (≥10%) in prophylaxis of aGVHD are anemia, hypertension, CMV reactivation/CMV infection, pyrexia, pneumonia, epistaxis, CD4 lymphocytes decreased, hypermagnesemia, and acute kidney injury. . Learn more.

Most common adverse reactions are: Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis: Reported during the first 3 months in rheumatoid arthritis placebo-controlled clinical trials and occurring in ≥2% of patients treated with XELJANZ monotherapy or in combination with DMARDs: upper respiratory tract infection, nasopharyngitis, diarrhea, and headache. Ulcerative Colitis: Reported in ≥5% of patients treated with either 5 mg or 10 mg twice daily of XELJANZ and ≥1% greater than reported in patients receiving placebo in either the induction or maintenance clinical trials: nasopharyngitis, elevated cholesterol levels, headache, upper respiratory tract infection, increased blood creatine phosphokinase, rash, diarrhea, and herpes zoster. Polyarticular Course Juvenile Idiopathic Arthritis: Consistent with common adverse reactions reported in adult rheumatoid arthritis patients.. Learn more.

Mechanism of Actions (MoA)

Selective Immunosuppressants . Learn more.

Janus Kinase Inhibitors. Learn more.

Special Populations

Is there a pregnancy exposure registry for ORENCIA?

Yes, there is a pregnancy exposure registry for ORENCIA that monitors pregnancy outcomes in women exposed to the drug during pregnancy. Healthcare professionals are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972.

What is the risk associated with ORENCIA use during pregnancy?

The data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. However, there are clinical considerations for administering live vaccines to infants who were exposed to ORENCIA while in utero (see Clinical Considerations).

What are the clinical considerations for administering live vaccines to infants who were exposed to ORENCIA while in utero?

It is unknown if abatacept, the active ingredient in ORENCIA, can cross the placenta into the fetus when a woman is treated with the drug during pregnancy. It is also unknown if the immune response of an infant who was exposed in utero to abatacept and subsequently administered a live vaccine is impacted. Risks and benefits should be considered prior to vaccinating such infants.

Is ORENCIA safe to use during lactation?

There is no information regarding the presence of abatacept, the active ingredient in ORENCIA, in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed with the drug.

Is ORENCIA safe to use in pediatric patients?

ORENCIA is safe and effective for reducing signs and symptoms in pediatric patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). Use of ORENCIA for this indication is supported by evidence from clinical studies. The safety and effectiveness of ORENCIA use in pJIA in pediatric patients less than two years of age have not been established.

Can geriatric patients use ORENCIA for Rheumatoid Arthritis?

Yes, geriatric patients (patients aged 65 years of age and older) can use ORENCIA for Rheumatoid Arthritis. Clinical studies involving 323 patients aged 65 years and older, including 53 patients aged 75 years and older, showed no overall differences in safety or effectiveness between geriatric patients and younger adults. However, caution should be used when treating geriatric patients due to the higher incidence of infections and malignancies in the geriatric population in general. The frequency of serious infection and malignancy among ORENCIA-treated patients over age 65 was higher than for those under age 65.

Are there differences in response between geriatric patients and younger adult patients using ORENCIA for Rheumatoid Arthritis?

Other reported clinical experience has not identified differences in responses between geriatric patients and younger adults when using ORENCIA for Rheumatoid Arthritis. However, greater sensitivity of some geriatric patients cannot be ruled out. Clinical studies of ORENCIA for acute graft versus host disease (aGVHD) did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

Is there a pregnancy exposure registry for XELJANZ/XELJANZ XR/XELJANZ Oral Solution?

Yes, there is a pregnancy exposure registry for XELJANZ/XELJANZ XR/XELJANZ Oral Solution that monitors pregnancy outcomes in women exposed to the drug during pregnancy. Patients should be encouraged to enroll in the registry if they become pregnant. To enroll or obtain information from the registry, patients can call the toll-free number 1-877-311-8972.

What is the risk associated with XELJANZ/XELJANZ XR/XELJANZ Oral Solution use during pregnancy?

Available data with XELJANZ/XELJANZ XR/XELJANZ Oral Solution use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. However, there are risks to the mother and the fetus associated with rheumatoid arthritis and UC in pregnancy. In animal reproduction studies, fetocidal and teratogenic effects were noted when pregnant rats and rabbits received tofacitinib during the period of organogenesis at exposures multiples of 73-times and 6.3-times the maximum recommended dose of 10 mg twice daily, respectively.

Are there any clinical considerations related to XELJANZ/XELJANZ XR/XELJANZ Oral Solution use during pregnancy?

Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis or ulcerative colitis. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.

What is the estimated background risk of major birth defects and miscarriage for the indicated populations?

The estimated background risks of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risks in the U.S. general population of major birth defects and miscarriages are 2 to 4% and 15 to 20% of clinically recognized pregnancies, respectively.

Is it safe to breastfeed while taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution?

No data is available on the presence of tofacitinib in human milk, the effects on a breastfed infant, or the effects on milk production. Tofacitinib is present in the milk of lactating rats. Given the serious adverse reactions seen in patients treated with XELJANZ/XELJANZ XR/XELJANZ Oral Solution, such as increased risk of serious infections, patients should be advised that breastfeeding is not recommended during treatment and for at least 18 hours after the last dose of XELJANZ/XELJANZ Oral Solution or 36 hours after the last dose of XELJANZ XR (approximately 6 elimination half-lives).

Does XELJANZ/XELJANZ XR/XELJANZ Oral Solution affect female fertility?

Based on findings in rats, treatment with XELJANZ/XELJANZ XR/XELJANZ Oral Solution may result in reduced fertility in females of reproductive potential. It is not known if this effect is reversible.

Is XELJANZ/XELJANZ Oral Solution safe for use in pediatric patients?

The safety and effectiveness of XELJANZ/XELJANZ Oral Solution have been established in patients 2 years to 17 years of age for the treatment of active pcJIA. The safety and efficacy of XELJANZ/XELJANZ Oral Solution in pediatric patients for indications other than pcJIA have not been established. The safety and effectiveness of XELJANZ XR in pediatric patients have not been established.

What is the frequency of serious infection among XELJANZ-treated subjects who are 65 years and older?

The frequency of serious infection among XELJANZ-treated subjects who are 65 years and older was higher than among those under the age of 65.

How should caution be used when treating the elderly with XELJANZ?

As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly with XELJANZ.

Should caution be used when treating patients with diabetes with XELJANZ?

Yes, caution should be used when treating patients with diabetes with XELJANZ as there is a higher incidence of infection in the diabetic population in general.

Is dosage adjustment required in XELJANZ-treated patients with mild renal impairment?

No, dosage adjustment is not required in XELJANZ-treated patients with mild renal impairment.

Is XELJANZ recommended for use in patients with severe hepatic impairment?

No, XELJANZ is not recommended for use in patients with severe hepatic impairment as it has not been studied in this population.

Is dosage adjustment required in XELJANZ-treated patients with mild hepatic impairment?

No, dosage adjustment is not required in XELJANZ-treated patients with mild hepatic impairment.

Has the safety and efficacy of XELJANZ been studied in patients with positive hepatitis B or C virus serology?

No, the safety and efficacy of XELJANZ have not been studied in patients with positive hepatitis B or C virus serology.

Orencia® Alternatives