Note: This document contains side effect information about abatacept. Some dosage forms listed on this page may not apply to the brand name Orencia.

Summary

Common side effects of Orencia include: headache and nasopharyngitis. Other side effects include: dyspepsia and hypertension. Continue reading for a comprehensive list of adverse effects.

Applies to abatacept: powder for solution, solution.

Serious side effects of Orencia

Along with its needed effects, abatacept (the active ingredient contained in Orencia) 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 while taking abatacept:

More common

• Agitation
• back pain
• bladder pain
• bloody or cloudy urine
• body aches or pain
• chest pain or tightness
• chills
• coma
• confusion
• cough
• cough producing mucus
• decreased urine output
• difficult, burning, or painful urination
• difficult or labored breathing
• dizziness
• ear congestion
• fever
• frequent urge to urinate
• headache
• hostility
• irritability
• lethargy
• loss of voice
• lower back or side pain
• muscle twitching
• nausea or vomiting
• noisy breathing
• pain or tenderness around the eyes and cheekbones
• rapid weight gain
• seizures
• sneezing
• sore throat
• stuffy or runny nose
• trouble breathing
• unusual tiredness or weakness

Less common

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

Rare

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

Incidence not known

• Redness, soreness, or itching of the skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• sores, welts, blisters

Other side effects of Orencia

Some side effects of abatacept 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

• Belching
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• heartburn
• indigestion
• stomach discomfort or upset

Less common

• Diarrhea
• pain in the arms or legs

For Healthcare Professionals

Applies to abatacept: intravenous powder for injection, subcutaneous solution.

Cardiovascular

Very common (10% or more): Hypertension (up to 49%)

Common (1% to 10%): Increased blood pressure

Uncommon (0.1% to 1%): Palpitations, tachycardia, bradycardia, hypotension, hot flush, flushing, vasculitis, decreased blood pressure

Frequency not reported: Hyperemia

Postmarketing reports: Vasculitis (including cutaneous vasculitis, leukocytoclastic vasculitis)^[Ref]

Dermatologic

Angioedema has occurred as early as after the first dose but also with subsequent doses. Angioedema reactions have occurred within hours of administration and in some cases had delayed onset (i.e., days).^[Ref]

Common (1% to 10%): Rash (including dermatitis)

Uncommon (0.1% to 1%): Onychomycosis, skin abscess, increased tendency to bruise, dry skin, alopecia, pruritus, urticaria, psoriasis, acne, erythema, hyperhidrosis, cellulitis, infected skin ulcer

Frequency not reported: Herpes simplex, acariasis, furuncle, tinea pedis, acarodermatitis, fungal rash, tinea versicolor, contusion, eczema, nail dystrophy, skin lesion, pityriasis

Postmarketing reports: New/worsening psoriasis, angioedema reactions, life-threatening cases of angioedema^[Ref]

Gastrointestinal

Very common (10% or more): Nausea

Common (1% to 10%): Dyspepsia, abdominal pain, diarrhea, mouth ulceration, aphthous stomatitis, vomiting, oral herpes

Uncommon (0.1% to 1%): Tooth infection, gastritis, diverticulitis

Rare (0.01% to 0.1%): Gastrointestinal infection

Frequency not reported: Upper abdominal pain, dry mouth, gastrointestinal hemorrhage, gastrointestinal pain, gingival ulceration, lip dry, gastroenteritis, tooth abscess^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Pyelonephritis, amenorrhea, menorrhagia, acute pyelonephritis, pelvic inflammatory disease, urosepsis

Frequency not reported: Ovarian cyst, genital herpes, cystitis, vaginal infection, bacteriuria, leukocyturia^[Ref]

Hematologic

Very common (10% or more): Anemia (up to 69%), CD4 lymphocytes decreased (up to 14%)

Uncommon (0.1% to 1%): Thrombocytopenia, leukopenia^[Ref]

Hepatic

Common (1% to 10%): Abnormal liver function test (including increased transaminases), increased ALT, increased AST

Frequency not reported: Abnormal hepatic function, increased transaminases, increased GGT^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reaction

Frequency not reported: Drug hypersensitivity (including hypotension, urticaria, dyspnea), anaphylaxis, anaphylaxis reactions

Postmarketing reports: Fatal anaphylaxis after first infusion^[Ref]

Immunologic

Common (1% to 10%): Autoimmune disorders (e.g., psoriasis, Raynaud's phenomenon, erythema nodosum), development of binding antibodies, immunogenicity

Frequency not reported: Neutralizing antibodies positive^[Ref]

Local

In adult rheumatoid arthritis patients, injection site reactions (including hematoma, pruritus, erythema) were mild (83%) to moderate (17%) in severity.^[Ref]

Common (1% to 10%): Local injection site reactions (subcutaneous formulation), injection site reactions (including hematoma, pruritus, erythema)

Frequency not reported: Infusion site extravasation, infusion site pain, infusion site swelling, infusion site erythema^[Ref]

Metabolic

Very common (10% or more): Hypermagnesemia (up to 18%)

Frequency not reported: Diabetes mellitus^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, pain in extremity

Uncommon (0.1% to 1%): Musculoskeletal infections, arthralgia

Frequency not reported: Myalgia, joint wear, soft tissue infection, joint swelling, ligament disorder, musculoskeletal stiffness, systemic lupus erythematosus, rheumatoid nodule, Sjogren's syndrome^[Ref]

Nervous system

Very common (10% or more): Headache (up to 18%)

Common (1% to 10%): Dizziness, herpes zoster

Uncommon (0.1% to 1%): Migraine, paresthesia, vertigo

Frequency not reported: Multiple sclerosis, dysgeusia^[Ref]

Ocular

Uncommon (0.1% to 1%): Conjunctivitis, dry eye, reduced visual acuity

Frequency not reported: Eye irritation, presbyopia^[Ref]

Oncologic

PTLD occurred in patients using this drug for acute graft versus host disease (aGVHD) prophylaxis during unrelated hematopoietic stem cell transplantation (HSCT). Of 116 patients who received this drug, 4 patients (3.4%) had PTLD; all of these events were associated with Epstein-Barr virus (EBV) infection. At baseline, 3 of the 4 patients were EBV serology positive; 1 patient had negative baseline EBV serology with donor EBV serology unknown. Acyclovir prophylaxis was stopped in 3 of the 4 patients at 30 days posttransplant; time to onset of events ranged from 49 to 89 days posttransplant.^[Ref]

Common (1% to 10%): Posttransplant lymphoproliferative disorder (PTLD), malignancies

Uncommon (0.1% to 1%): Basal cell carcinoma, skin papilloma, lung cancer

Rare (0.01% to 0.1%): Lymphoma, malignant lung neoplasm, squamous cell carcinoma

Frequency not reported: Skin cancer, breast cancer, bile duct cancer, bladder cancer, cervical cancer, endometrial cancer, melanoma, myelodysplastic syndrome, ovarian cancer, prostate cancer, renal cancer, thyroid cancer, uterine cancer, acute lymphocytic leukemia, lung neoplasm

Postmarketing reports: Nonmelanoma skin cancers (basal cell carcinoma, squamous cell carcinoma)^[Ref]

Other

In clinical trials, infections at least possibly related to therapy were reported in 22.7% of patients treated with this drug compared to 20.5% of patients treated with placebo. Serious infections at least possibly related to therapy were reported in 1.5% of patients treated with this drug and 1.1% of placebo-treated patients; the type of serious infections was similar between both treatment groups.

In clinical trials in rheumatoid arthritis patients, infections were reported in 54% of patients treated with this drug IV compared to 48% treated with placebo. The infections reported most often (up to 13%) were upper respiratory tract infection, nasopharyngitis, sinusitis, urinary tract infection, influenza, and bronchitis; other infections reported in less than 5% of patients were rhinitis, herpes simplex, and pneumonia.

In clinical trials in patients with adult rheumatoid arthritis, patients coadministered this drug IV and tumor necrosis factor (TNF) antagonist therapy had more infections and serious infections (63% and 4.4%, respectively) compared to patients treated with only TNF antagonists (43% and 0.8%, respectively).

Serious infections (including sepsis, pneumonia) have been reported in patients receiving this drug; serious infections were reported in 3% of rheumatoid arthritis patients treated with the IV formulation. Some of these infections were fatal. Many of the serious infections occurred in patients on concomitant immunosuppressive therapy which, along with underlying disease, may have further predisposed them to infection. A higher rate of serious infections has been observed in adult rheumatoid arthritis patients treated with concomitant TNF antagonists and this drug compared to those treated with this drug alone.

CMV invasive disease occurred in patients using this drug for aGVHD prophylaxis during unrelated HSCT. Of 116 patients who received this drug, 7% had CMV invasive diseases up to day 225 posttransplant; all patients with CMV invasive disease were CMV serology positive at baseline. The median time to event onset was 91 days posttransplant; CMV invasive diseases primarily involved the gastrointestinal tract.

Acute infusion-related events (side effects occurring within 1 hour of the start of the infusion) were more common in patients treated with this drug than those treated with placebo; the most frequently reported events (up to 2%) were dizziness, headache, and hypertension.

Acute infusion-related events that were uncommon included cardiopulmonary symptoms (e.g., hypotension, decreased blood pressure, tachycardia, bronchospasm, dyspnea); other symptoms included myalgia, nausea, erythema, flushing, urticaria, cough, hypersensitivity, pruritus, throat tightness, chest discomfort, chills, infusion site extravasation, infusion site pain, infusion site swelling, infusion-related reaction, rash, and wheezing. Most of these reactions were mild (68%) to moderate (28%) in severity.

Very common (10% or more): Infections (up to 63%), CMV reactivation/CMV infection (up to 32%), pyrexia (up to 28%)

Common (1% to 10%): Serious infections (including sepsis, pneumonia), CMV invasive disease, herpes infections (including herpes simplex, oral herpes, herpes zoster), fatigue, asthenia, systemic injection reactions (e.g., pruritus, throat tightness, dyspnea), acute infusion-related events, increased weight

Uncommon (0.1% to 1%): Localized infection, sepsis, ear infection, influenza-like illness

Rare (0.01% to 0.1%): Tuberculosis, bacteremia

Frequency not reported: Chest discomfort, chills, infusion-related reaction, varicella infection, disease flare, EBV reactivation, malaise, chest pain, axillary pain, feeling hot, sudden death, bacterial infection, increased blood alkaline phosphatase, breast mass, breast pain, otitis externa

Postmarketing reports: Systemic infusion reactions after IV formulation, systemic injection reactions (e.g., pruritus, throat tightness, dyspnea) after subcutaneous formulation

Psychiatric

Uncommon (0.1% to 1%): Depression, anxiety, sleep disorder (including insomnia)

Frequency not reported: Insomnia, nervousness^[Ref]

Renal

Very common (10% or more): Acute kidney injury (up to 15%)^[Ref]

Respiratory

Very common (10% or more): Respiratory disorders (including chronic obstructive pulmonary disease [COPD] exacerbation, cough, rhonchi, dyspnea; up to 43%), pneumonia (up to 19%), epistaxis (up to 16%), nasopharyngitis (up to 12%), upper respiratory tract infection (including tracheitis, nasopharyngitis, sinusitis)

Common (1% to 10%): Lower respiratory tract infection (including bronchitis), cough, sinusitis, bronchitis, influenza, pharyngitis

Uncommon (0.1% to 1%): Rhinitis, COPD exacerbated, bronchospasm, wheezing, dyspnea, throat tightness

Frequency not reported: Rhonchi, respiratory tract infection, tonsillitis, viral upper respiratory tract infection, bronchopneumonia, laryngitis, pseudomonal lung infection, nasal congestion, pharyngolaryngeal pain, rhinorrhea, sinus congestion, exertional dyspnea, nasal discomfort, nasal dryness^[Ref]