Kaletra Side Effects

Generic name: lopinavir / ritonavir

Note: This document contains side effect information about lopinavir / ritonavir. Some of the dosage forms listed on this page may not apply to the brand name Kaletra.

Some side effects of Kaletra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to lopinavir / ritonavir: oral liquid, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking lopinavir / ritonavir: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medication and call your doctor at once if you have:

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• severe pain in your upper stomach spreading to your back, nausea and vomiting;

• itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• high blood sugar (increased thirst, increased urination);

• penis erection that is painful or lasts 4 hours or longer (if you take Kaletra with erectile dysfunction medication);

• diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;

• swelling in your neck or throat (enlarged thyroid);

• muscle weakness, tired feeling, joint or muscle pain, feeling short of breath;

• problems with walking, breathing, speech, swallowing, or eye movement;

• weakness or prickly feeling in your fingers or toes, severe lower back pain, loss of bladder or bowel control; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• mild nausea, upset stomach;

• headache, weakness;

• mild stomach pain; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to lopinavir / ritonavir: oral capsule, oral liquid, oral tablet

General

Diarrhea, usually of mild to moderate severity, is the most common side effect associated with lopinavir-ritonavir. During 48 weeks of one study, diarrhea (any severity) occurred in 60% of patients receiving lopinavir-ritonavir tablets once a day compared to 57% receiving the tablets twice a day. In the same trial, treatment was discontinued in 4.8% of patients receiving lopinavir-ritonavir tablets once a day as compared to 3% receiving twice daily dosing due to any adverse effects. During 48 weeks of a different study, diarrhea (any severity) occurred in 50% of patients receiving lopinavir-ritonavir tablets once a day compared to 39% receiving the tablets twice a day. Moderate or severe drug-related diarrhea reported in this study occurred in 14% of patients receiving the once daily regimen as compared to 11% receiving the twice daily regimen. In the same trial, treatment was discontinued due to any side effect in 4.3% of patients receiving lopinavir-ritonavir tablets once a day as compared to 7% receiving twice daily dosing. During another clinical trial, discontinuations due to side effects were observed in 3.4% of patients receiving lopinavir-ritonavir versus 3.7% receiving comparator.

Cardiovascular

Cardiovascular side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included hypertension (up to 3%), distended veins (3%), and angina pectoris, atrial fibrillation, atrioventricular (AV) block, myocardial infarction, cerebral infarction, deep vein thrombosis, chest pain, hypertension, palpitation, postural hypotension, tricuspid valve incompetence, thrombophlebitis, varicose vein, and vasculitis in less than 2% of adult patients. Sinus arrest and bradycardia-tachycardia syndrome have also been reported. Bradyarrhythmias, first-degree AV block, second-degree AV block, third-degree AV block, QTc interval prolongation, and torsades de pointes have been reported during postmarketing experience.

Dermatologic

Dermatologic side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included rash (up to 5%) and acne, alopecia, dry skin, eczema, acneiform dermatitis, allergic dermatitis, exfoliative dermatitis, cellulitis, folliculitis, furunculosis, lipomatosis, idiopathic capillaritis, maculopapular rash, generalized rash, nail disorder, seborrhea, pruritus, benign skin neoplasm, skin discoloration, skin hypertrophy, skin ulcer, skin striae, swelling face, and hyperhidrosis in less than 2% of patients. Acute generalized exanthematous pustulosis has also been reported. Toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme have been reported during postmarketing experience.

Endocrine

Episodes of hyperglycemia, new onset diabetes mellitus, and exacerbation of preexisting diabetes mellitus have been reported during postmarketing studies in HIV-infected patients receiving protease inhibitors. In some cases, diabetic ketoacidosis has occurred. No causal relationship has been established. Careful monitoring of blood glucose levels should be done and either initiation or dose adjustments of insulin or oral hypoglycemic agents may be needed.

Endocrine side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included Cushing's syndrome, diabetes mellitus, and hypothyroidism in less than 2% of patients. Ketoacidosis has been reported.

Gastrointestinal

Pancreatitis, including fatalities, has occurred in patients receiving lopinavir-ritonavir therapy, including those who developed hypertriglyceridemia. Although a causal relationship has not been established, marked triglyceride elevation is a risk factor for the development of pancreatitis. Patients who experience signs or symptoms of pancreatitis should be evaluated and lopinavir-ritonavir should be stopped if a diagnosis of pancreatitis is made.

Gastrointestinal side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included diarrhea (7% to 28%), nausea (3% to 16%), vomiting (2% to 6%), abdominal pain (up to 11%), abnormal stools (up to 6%), dyspepsia (up to 6%), dysphagia (up to 2%), flatulence (1% to 4%), upper abdominal pain (up to 2%), and anorexia (up to 2%). Cholangitis, cholecystitis, abdominal discomfort, abdominal distention, lower abdomen pain, constipation, duodenitis, dry mouth, enterocolitis, eructation, esophagitis, fecal incontinence, gastric disorder, gastric ulcer, gastritis, gastroesophageal reflux disease, hemorrhoids, gastroenteritis, hemorrhagic enterocolitis, increased and decreased appetite, pancreatitis, periodontitis, rectal hemorrhage, sialadenitis, stomatitis, stomach discomfort, and ulcerative stomatitis have been reported in less than 2% of patients.

Genitourinary

Genitourinary side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included hypogonadism (2%) and ejaculation disorder, breast enlargement, gynecomastia, hematuria, impotence, menorrhagia, abnormal urine odor, and urine abnormality in less than 2% of patients.

Hematologic

Hematologic side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included decreased neutrophil counts (up to 5%), decreased hemoglobin (up to 2%), and anemia, leukopenia, splenomegaly, and lymphadenopathy in less than 2% of patients. Hemolytic anemia and spontaneous bleeding in hemophiliacs have been reported rarely.

Hepatic

Hepatic side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included elevated AST (1% to 10%), ALT (1% to 11%), and GGT (up to 29%) levels, and jaundice, fatty liver deposit, cytolytic hepatitis, hepatic steatosis, hepatitis, hepatomegaly, and liver tenderness (less than 2% each). Hepatic failure has also been reported.

Lopinavir-ritonavir is primarily metabolized by the liver. Caution should be used when administering this drug to patients with hepatic impairment because lopinavir levels may be increased. Patients with underlying hepatitis B or C or marked elevations in transaminases before initiation of therapy may be at an increased risk for developing further transaminase elevations or liver decompensation. There have been reports of hepatic dysfunction with some cases leading to death. A causal relationship with lopinavir-ritonavir administration has not been proven since these cases have generally occurred in patients with advanced HIV who also had underlying chronic hepatitis or cirrhosis and were taking multiple concomitant medications.

Metabolic

Metabolic side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included elevations in amylase (3% to 8%), bilirubin (1% to 3%), blood glucose (up to 5%), creatine phosphokinase (up to 5%), total cholesterol (3% to 39%), triglycerides (3% to 36%), uric acid (up to 5%), and lipase (up to 5%), decreased phosphorus levels (up to 2%), and weight loss (up to 3%). Avitaminosis, hypovitaminosis, dehydration, decreased glucose tolerance, lactic acidosis, obesity, and weight gain have been reported in less than 2% of patients. Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy. Redistribution/accumulation of body fat has been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have included myalgia (up to 2%) and arthralgia, arthropathy, back pain, arthrosis, muscular weakness, osteonecrosis, joint disorder, osteoarthritis, extremity pain, and myasthenia in less than 2% of patients receiving lopinavir-ritonavir with other antiretroviral agents.

Nervous system

Nervous system side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included headache (up to 7%), insomnia (up to 3%), decreased libido (up to 2%), and paresthesia (up to 2%). Amnesia, ataxia, balance disorder, convulsion, dizziness, dyskinesia, encephalopathy, facial paralysis, hypertonia, migraine, neuropathy, peripheral neuropathy, peripheral neuritis, somnolence, hyperacusis, tinnitus, tremor, extrapyramidal syndrome, ageusia, dysgeusia, and vertigo have been reported in less than 2%.

Psychiatric

Psychiatric side effects have included depression (up to 3%), and abnormal dreams, affect lability, agitation, anxiety, apathy, confusional state, disorientation, mood swings, nervousness, and abnormal thinking in less than 2% of patients.

Ocular

Ocular side effects have included visual disturbance and eye disorder in less than 2% of patients receiving lopinavir-ritonavir with other antiretroviral agents.

Other

Other side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included asthenia (up to 9%), pyrexia (up to 2%), chills (up to 2%), and generalized pain, back pain, back and abdomen enlargement, chest pain, cyst, edema, peripheral edema, fatigue, face edema, flu syndrome, hypertrophy, malaise, lymphadenopathy, drug interaction, and increased drug level in less than 2% of patients. Elevated creatine kinase has also been reported.

Immunologic

Immunologic side effects have included immune reconstitution syndrome, infection (bacterial and viral), influenza, otitis media, and perineal abscess (less than 2%). Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution.

Oncologic

Oncologic side effects have included neoplasm and lipoma in less than 2% of patients when lopinavir-ritonavir was administered with other antiretroviral agents.

Renal

Renal side effects have included decreased calculated creatinine clearance (up to 3%) and kidney calculus, nephritis, and renal disorder in less than 2% of patients when lopinavir-ritonavir was administered with other antiretroviral agents.

Respiratory

Respiratory side effects have included bronchitis (up to 2%) and asthma, bronchopneumonia, dyspnea, lung edema, pharyngitis, rhinitis, increased cough, and sinusitis in less than 2% of patients receiving lopinavir-ritonavir with other antiretroviral agents.

Hypersensitivity

Hypersensitivity side effects have included drug hypersensitivity and hypersensitivity in less than 2% of patients receiving lopinavir-ritonavir in combination with other antiretroviral agents. At least one case of a severe skin and mucous hypersensitivity reaction with transient multiorgan failure has been reported.

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