Note: This document contains side effect information about adalimumab. Some dosage forms listed on this page may not apply to the brand name Yuflyma.
Applies to adalimumab: subcutaneous solution.
Warning
Subcutaneous route (Solution)
Serious InfectionsPatients treated with adalimumab products including adalimumab-aqvh are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.Discontinue adalimumab-aqvh if a patient develops a serious infection or sepsis.Reported infections include:Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before adalimumab-aqvh use and during therapy. Initiate treatment for latent TB prior to adalimumab-aqvh use.Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.Carefully consider the risks and benefits of treatment with adalimumab-aqvh prior to initiating therapy in patients with chronic or recurrent infection.Monitor patients closely for the development of signs and symptoms of infection during and after treatment with adalimumab-aqvh, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.MalignancyLymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.
Serious side effects of Yuflyma
Along with its needed effects, adalimumab (the active ingredient contained in Yuflyma) 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 immediately if any of the following side effects occur while taking adalimumab:
More common
- Blurred vision
- body aches or pain
- chills
- cough
- dizziness
- ear congestion
- fever
- headache
- loss of voice
- pounding in the ears
- slow or fast heartbeat
- sneezing
- stuffy or runny nose
- trouble breathing
- unusual tiredness or weakness
Less common
- Abnormal healing
- agitation
- anxiety
- arm, back, jaw pain
- bleeding from the gums or nose
- blindness
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or black, tarry stools
- bloody or cloudy urine
- blue or pale skin
- bone pain or fractures
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain, discomfort, tightness, or heaviness
- coma
- confusion
- cough or hoarseness
- dark urine
- decreased vision
- depression
- diarrhea
- difficulty in moving
- difficulty in swallowing
- drowsiness
- dry mouth
- dry skin
- eye pain
- fainting
- feeling of illness
- frequent urge to urinate
- gaseous stomach pain
- hair loss
- hallucinations
- heartburn
- increased thirst
- increased urination
- indigestion
- irritability
- itching
- loss of appetite
- loss of strength or energy
- light-colored stools
- lower back or side pain
- mood or mental changes
- muscle pain, stiffness, cramps, tightness, rigidity, or spasms
- nausea
- no blood pressure or pulse
- pain, swelling, or redness in the joints
- pain in the arms or legs
- pain in the groin or genitals
- pain or burning in the throat
- painful or difficult urination
- pale skin
- pelvic pain
- rapid breathing
- rapid weight gain or loss
- rash
- recurrent fever
- redness or swelling of the lower leg
- ringing in the ears
- seizures
- shakiness in the legs, arms, hands, or feet
- sharp back pain just below ribs
- sore throat
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
- stiff neck
- stomach pain
- stopping of the heart
- sunken eyes
- sweating
- tingling of the hands or feet
- trembling or shaking of the hands or feet
- trouble thinking
- unconsciousness
- unpleasant breath odor
- unusual bleeding or bruising
- unusual weight gain or loss
- visual disturbances
- vomiting
- vomiting of blood or material that looks like coffee grounds
- wrinkled skin
- yellow eyes or skin
Incidence not known
- Blistering, peeling, or loosening of skin
- blisters on the skin
- blue-yellow color blindness
- inability to move arms and legs
- red irritated eyes
- red skin lesions, often with a purple center
- sudden numbness and weakness in the arms and legs
- swelling in the arm or leg
Other side effects of Yuflyma
Some side effects of adalimumab 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
- Bleeding, blistering, burning, coldness, discoloration of 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
- pain or tenderness around eyes and cheekbones
Incidence not known
- Loss or thinning of the hair
For Healthcare Professionals
Applies to adalimumab: subcutaneous kit, subcutaneous solution.
Cardiovascular
Common (1% to 10%): Hypertension
Uncommon (0.1% to 1%): Arrhythmia, atrial fibrillation, chest pain, coronary artery disorder, heart arrest, hypertensive encephalopathy, myocardial infarct, palpitation, pericardial effusion, pericarditis, syncope, tachycardia, congestive heart failure, peripheral edema, systemic vasculitis, deep vein thrombosis
Rare (less than 0.1%): Vascular occlusion, aortic stenosis, thrombophlebitis, aortic aneurysm[Ref]
Dermatologic
Very common (10% or more): Rash (12%)
Common (1% to 10%): Dermatitis, eczema, pruritus, cellulitis, urticaria, psoriasis, ecchymosis, increased bruising, purpura, erysipelas, cutaneous vasculitis, herpes zoster
Postmarketing reports: Stevens Johnson Syndrome, cutaneous vasculitis, erythema multiforme, new or worsening psoriasis (all subtypes including pustular and palmoplantar), alopecia, erythema multiforme, panniculitis[Ref]
Endocrine
Uncommon (0.1% to 1%): Parathyroid disorder[Ref]
Gastrointestinal
Common (1% to 10%): Diarrhea, nausea, abdominal pain, vomiting, stomatitis, mouth ulceration
Uncommon (0.1% to 1%): Cholecystitis, cholelithiasis, gastroenteritis, gastrointestinal hemorrhage, gastritis, dyspepsia, gastrointestinal disorder, gastrointestinal hemorrhage, rectal hemorrhage, abdominal bloating
Rare (less than 0.1%): Esophagitis, intestinal stenosis, colitis, enteritis
Frequency not reported: Diverticulitis, large bowel perforations including perforations associated with diverticulitis and appendiceal perforations associated with appendicitis, pancreatitis[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection, hematuria
Uncommon (0.1% to 1%): Cystitis, kidney calculus, menstrual disorder, pyelonephritis[Ref]
Hematologic
Common (1% to 10%): Lymphopenia, agranulocytosis, granulocytopenia, leucopenia, thrombocytopenia, anemia, lymphadenopathy, leukocytosis
Rare (less than 0.1%): Pancytopenia, polycythemia, idiopathic thrombocytopenia purpura, lymphoma-like reaction, leg thrombosis, hypertriglyceridemia[Ref]
Hepatic
Uncommon (0.1% to 1%): Liver failure, hepatitis
Rare (less than 0.1%): Hepatic enzymes increased, hepatic necrosis
Postmarketing reports: Hepatic failure[Ref]
Hypersensitivity
Frequency not reported: Anaphylaxis, angioneurotic edema[Ref]
Immunologic
Common (1% to 10%): Flu syndrome
Uncommon (0.1% to 1%): Sarcoidosis
Frequency not reported: Development of autoantibodies[Ref]
Local
Very common (10% or more): Injection site pain (12%)
Common (1% to 10%): Injection site reaction[Ref]
Metabolic
Common (1% to 10%): Hypercholesterolemia, hyperlipidemia
Uncommon (0.1% to 1%): Dehydration, ketosis, paraproteinemia, increased alkaline phosphatase[Ref]
Musculoskeletal
Common (1% to 10%): Back pain
Uncommon (0.1% to 1%): Arthritis, bone disorder, bone fracture (not spontaneous), bone necrosis, joint disorder, muscle cramps, myasthenia, pyogenic arthritis, synovitis, tendon disorder, pelvic pain
Rare (less than 0.1%): Rhabdomyolysis[Ref]
Nervous system
Very common (10% or more): Headache (12%)
Uncommon (0.1% to 1%): Confusion, paraesthesia, subdural hematoma, tremor, demyelinating disorders (e.g., optic neuritis, Guillain-Barre syndrome), cerebrovascular accident, multiple sclerosis,
Very rare (less than 0.01%): Hypertrophic pachymeningitis[Ref]
Ocular
Uncommon (0.1% to 1%): Optic neuritis, cataract[Ref]
Oncologic
Uncommon (0.1% to 1%): Adenoma, Merkel Cell Carcinoma (neuroendocrine carcinoma of the skin)
Rare (less than 0.1%): Skin papilloma, carcinomas (breast, gastrointestinal, skin, testicular), lymphoma, melanoma, cancer of the white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL), mostly in adolescents and young adults[Ref]
Other
Very common (10% or more): Accidental injury (10%)
Uncommon (0.1% to 1%): Pain in extremity, thorax pain
Rare (less than 0.1%): Pyrexia
Frequency not reported: Sepsis, pain in thorax, opportunistic infections, tuberculosis, histoplasmosis, abscess, joint infection, wound infection, superficial fungal infections[Ref]
Renal
Frequency not reported: Renal pain, renal impairment[Ref]
Respiratory
Very common (10% or more): Upper respiratory infection (17%), sinusitis (11%), pneumonia, pharyngitis, nasopharyngitis
Uncommon (0.1% to 1%): Asthma, bronchospasm, dyspnea, lung function decreased, pleural effusion, interstitial lung disease (including pulmonary fibrosis), pulmonary embolism
Frequency not reported: Cough, upper respiratory infection, pharyngeal edema, nasal congestion, pulmonary edema, pleural effusion, pleurisy[Ref]
Psychiatric
Common (1% to 10%): Mood alterations (including depression), anxiety, insomnia[Ref]
