Summary

Commonly reported side effects of belatacept include: cytomegalovirus disease. Continue reading for a comprehensive list of adverse effects.

Applies to belatacept: intravenous powder for solution.

Serious side effects of Belatacept

Along with its needed effects, belatacept 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

• Abdominal or stomach pain
• agitation
• black, tarry stools
• bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• blurred vision
• bone pain
• burning while urinating
• chest pain
• chills
• coma
• confusion
• convulsions
• cough or hoarseness
• decreased frequency or amount of urine
• decreased urine output
• depression
• difficult or labored breathing
• difficult, burning, or painful urination
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• dry mouth
• fainting
• fast or irregular heartbeat
• fever
• frequent urge to urinate
• headache
• hostility
• inability to move the arms and legs
• increased blood pressure
• increased thirst
• irritability
• itching in other skin areas
• lethargy
• loss of appetite
• loss of bladder control
• lower back or side pain
• mood or mental changes
• muscle pain or cramps
• muscle spasms (tetany) or twitching
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pale skin
• pounding in the ears
• rapid weight gain
• scaling
• shortness of breath
• slow or fast heartbeat
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stupor
• sudden decrease in the amount of urine
• sudden numbness and weakness in the arms and legs
• sweating
• swelling of the face, ankles, or hands
• swollen glands
• tightness in the chest
• trembling
• troubled breathing
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• weakness or heaviness of the legs
• weight gain
• wheezing

Less common

• Back pain
• coughing or spitting up blood
• drowsiness
• joint pain, stiffness, or swelling
• loss of appetite
• night sweats
• persistent non-healing sore
• pink growth reddish patch or irritated area
• shiny bump
• sudden high fever or low-grade fever for months
• swelling of the feet or lower legs
• weight gain
• white, yellow, or waxy scar-like area

Other side effects of Belatacept

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

• Abdominal or stomach cramps
• blemishes on the skin
• body aches or pain
• collection of blood under the skin
• cough producing mucus
• deep, dark purple bruise
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty with moving
• dry mouth
• ear congestion
• flushed, dry skin
• fruit-like breath odor
• hair loss or thinning of the hair
• increased hunger
• increased sweating
• increased urination
• itching, pain, redness, or swelling
• loss of consciousness
• loss of voice
• muscle cramps in the hands, arms, feet, legs, or face
• muscle or bone pain
• muscle pain or stiffness
• numbness and tingling around the mouth, fingertips, or feet
• pain in the joints
• pimples
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• sleeplessness
• sneezing
• swelling or inflammation of the mouth
• tightness in the chest
• tremor
• trouble sleeping
• unable to sleep
• unexplained weight loss

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]