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Nulojix Side Effects

Generic name: belatacept

Medically reviewed by Drugs.com. Last updated on Jun 21, 2023.

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

Applies to belatacept: intravenous powder for solution.

Warning

Intravenous route (Powder for Solution)

Increased risk for developing posttransplant lymphoproliferative disorder (PTLD), predominantly involving the CNS. Recipients without immunity to Epstein-Barr virus (EBV) are at a particularly increased risk; therefore, use in EBV-seropositive patients only. Do not use belatacept in transplant recipients who are EBV seronegative or with unknown EBV serostatus. Only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe belatacept. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. Increased susceptibility to infection and the possible development of malignancies may result from immunosuppression. Use in liver transplant patients is not recommended due to an increased risk of graft loss and death.

Serious side effects of Nulojix

Along with its needed effects, belatacept (the active ingredient contained in Nulojix) 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 belatacept:

More common

Less common

Other side effects of Nulojix

Some side effects of belatacept 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

For Healthcare Professionals

Applies to belatacept: intravenous powder for injection.

Immunologic

Very common (10% or more): Infections (82%), serious infections (36%), herpes infection (14%), cytomegalovirus (12%)

Common (1% to 10%): Blood immunoglobulin G decreased, blood immunoglobulin M decreased, sepsis, influenza, herpes zoster, herpes simplex, BK virus infection, candidiasis, cellulitis, wound infection, localized infection, fungal infection

Uncommon (0.1% to 1%): Hypogammaglobinemia, progressive multifocal leukoencephalopathy, cerebral fungal infection, cytomegalovirus (CMV) colitis, polyomavirus-associated nephropathy, genital herpes, staphylococcal infection, endocarditis, tuberculosis (TB), bronchiectasis, strongyloidiasis, blastocystis infection, giardiasis, lymphangitis, Guillain-Barre syndrome, polyoma virus[Ref]

Cardiovascular

Very common (10% or more): Hypertension (32%), hypotension (18%)

Common (1% to 10%): Tachycardia, bradycardia, atrial fibrillation, cardiac failure, angina pectoris, left ventricular hypertrophy, shock, infarction, hematoma, lymphocele, angiopathy, arterial fibrosis

Uncommon (0.1% to 1%): Acute coronary syndrome, atrioventricular block second degree, aortic valve disease, arrhythmia supraventricular, venous thrombosis, arterial thrombosis, thrombophlebitis, arterial stenosis, intermittent claudication, flushing[Ref]

Dermatologic

Common (1% to 10%): Onychomycosis, acne, pruritus, alopecia, skin lesion, rash, night sweats, hyperhidrosis

Uncommon (0.1% to 1%): Psoriasis, hair growth abnormal, onychoclasis, penile ulceration, swelling face, trichorrhexis, alopecia[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (39%), constipation (33%), nausea (24%), vomiting (22%), abdominal pain (19%)

Common (1% to 10%): Gastroenteritis, oral candidiasis, dyspepsia, aphthous stomatitis, abdominal hernia, stomatitis

Uncommon (0.1% to 1%): Cholelithiasis, ulcer, GI disorder, pancreatitis, large intestinal ulcer, melena, gastroduodenal ulcer, rectal hemorrhage, small intestinal obstruction, cheilitis, gingival hyperplasia, salivary gland pain, feces discolored[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (37%), hematuria (16%), proteinuria (16%), dysuria (11%)

Common (1% to 10%): Hydrocele, glycosuria

Uncommon (0.1% to 1%): Epididymitis, priapism, cervical dysplasia, breast mass, testicular pain, vulval ulceration, atrophic vulvovaginitis, infertility, scrotal edema, urinary incontinence, urinary retention, nocturia, epididymitis, hemorrhagic cystitis, genital herpes[Ref]

Hematologic

Very common (10% or more): Anemia (45%), leukopenia (20%)

Common (1% to 10%): Thrombocytopenia, neutropenia, leukocytosis, polycythemia, lymphopenia, hematoma

Uncommon (0.1% to 1%): Monocytopenia, pure red cell aplasia, agranulocytosis, hemolysis, hypercoagulation[Ref]

Metabolic

Very common (10% or more): Hypokalemia (21%), hyperkalemia (20%), hypophosphatemia (19%), dyslipidemia (19%), hyperglycemia (16%), hypercholesterolemia (11%)

Common (1% to 10%): Weight increase, diabetes mellitus, dehydration, weight decrease, acidosis, fluid retention, hypoproteinemia, hypomagnesemia, hyperuricemia

Uncommon (0.1% to 1%): Diabetic ketoacidosis, diabetic foot, alkalosis, decreased appetite, vitamin D deficiency[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (17%), back pain (13%)

Common (1% to 10%): Chest pain, musculoskeletal pain

Uncommon (0.1% to 1%): Osteomyelitis

Frequency not reported: Extremity pain, myalgia, muscular weakness, bone pain, joint swelling, intervertebral disc disorder, joint lock, muscle spasms, bone metabolism disorder, osteitis, osteolysis, synovitis, osteoarthritis[Ref]

Nervous system

Very common (10% or more): Headache

Common (1% to 10%): Tremor, paraesthesia, cerebrovascular accident, dizziness, syncope, lethargy, peripheral neuropathy

Uncommon (0.1% to 1%): Encephalitis, Guillain-Barre syndrome, brain edema, intracranial pressure increased, encephalopathy, convulsion, hemiparesis, demyelination, facial palsy, dysgeusia, cognitive disorder, memory impairment, migraine, burning sensation, diabetic neuropathy, restless leg syndrome[Ref]

Oncologic

Common (1% to 10%): Squamous cell carcinoma of skin, basal cell carcinoma, skin papilloma

Uncommon (0.1% to 1%): EBV associated lymphoproliferative disorder, lung cancer, rectal cancer, breast cancer, sarcoma, Kaposi's sarcoma, prostate cancer, cervix carcinoma, laryngeal cancer, lymphoma, multiple myeloma, transitional cell carcinoma[Ref]

Psychiatric

Very common (10% or more): Insomnia (15%), anxiety (10%)

Common (1% to 10%): Depression

Uncommon (0.1% to 1%): Abnormal dreams, mood swings, attention deficit/hyperactivity disorder, libido increased, irritability[Ref]

Renal

Very common (10% or more): Blood creatinine increased (5%), proteinuria, dysuria, hematuria

Common (1% to 10%): Pyelonephritis, renal tubular necrosis, renal vein thrombosis, renal artery stenosis, glycosuria, hydronephrosis, vesicoureteric reflux, urinary incontinence, urinary retention, nocturia

Uncommon (0.1% to 1%): Renal artery thrombosis, nephritis, nephrosclerosis, renal tubular atrophy, cystitis hemorrhagic, kidney fibrosis[Ref]

Respiratory

Very common (10% or more): Cough (24%), upper respiratory tract infection (15%), nasopharyngitis (13%), dyspnea (12%), bronchitis (10%)

Common (1% to 10%): Pneumonia, sinusitis, rhinitis, pulmonary edema, wheezing, hypocapnia, orthopnea, epistaxis, oropharyngeal pain

Uncommon (0.1% to 1%): Acute respiratory distress syndrome, pulmonary hypertension, pneumonitis, hemoptysis, bronchopneumopathy, painful respiration, pleural effusion, sleep apnea syndrome, dysphonia, oropharyngeal blistering, bronchiectasis, lymphangitis[Ref]

Hepatic

Common (1% to 10%): Cytolytic hepatitis, liver function test abnormal

Uncommon (0.1% to 1%): Hepatic cyst, hepatic steatosis, cholelithiasis[Ref]

Local

Uncommon (0.1% to 1%): Infusion related reaction[Ref]

Ocular

Common (1% to 10%): Cataract, ocular hyperemia, blurred vision

Uncommon (0.1% to 1%): Retinitis, conjunctivitis, eye inflammation, keratitis, photophobia, eyelid edema[Ref]

Other

Very common (10% or more): Pyrexia, peripheral edema

Common (1% to 10%): Vertigo, ear pain, tinnitus, fatigue, malaise, impaired healing, C-reactive protein increased, blood parathyroid hormone increased

Uncommon (0.1% to 1%): Hypoacusis, fibrosis, inflammation, feeling hot[Ref]

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Nulojix (belatacept). Bristol-Myers Squibb. 2011.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.