Kaletra Tablets
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Kaletra Tablets
Kaletra Tablets Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Kaletra (lopinavir/ritonavir) is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). It is not a cure for HIV or AIDS. Kaletra is a combination of two antiviral medications called protease inhibitors. Common side effects include diarrhea, headache, nausea, vomiting, stomach upset, drowsiness, dizziness, a bad taste in the mouth, and trouble sleeping.
The recommended dose of Kaletra tablets is 400/100 mg (given as two 200/50 mg tablets) twice daily. The recommended dose of Kaletra oral solution is 400/100 mg (5 mL) twice daily. Kaletra may interact with fluticasone, rifabutin, itraconazole, ketoconazole, antidepressants, blood thinners, calcium channel blockers, cholesterol-lowering medicines, drugs that weaken the immune system, heart rhythm medications, other HIV /AIDS medicines, insulin or oral diabetes medication, medicines to treat erectile dysfunction, or seizure medications. Many other medicines can interact with Kaletra. Tell your doctor all prescription and over-the-counter medications you use. Kaletra should be used only when prescribed during pregnancy. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.
Our Kaletra (lopinavir/ritonavir) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Kaletra Tablets in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking lopinavir and ritonavir and call your doctor at once if you have any of these serious side effects:
- dizziness, fainting, fast or pounding heartbeats;
- vision changes;
- increased urination or extreme thirst;
- penis erection that is painful or lasts longer than 4 hours;
- signs of a new infection, such as fever or chills, cough, or flu symptoms;
- severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
- loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); 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.
Less serious side effects may include:
- mild nausea, vomiting, diarrhea, upset stomach;
- mild skin rash;
- headache, weakness, feeling tired; 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. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Kaletra Tablets (Lopinavir, Ritonavir Tablets) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Kaletra Tablets Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).
Tell your doctor immediately if any of these unlikely but serious side effects occur: increased thirst, increased urination, confusion, persistent nausea/vomiting, severe stomach pain, yellowing of skin/eyes, dark urine.
Seek immediate medical attention if any of these rare but very serious side effects occur: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), severe dizziness, fainting, slow/fast/irregular heartbeat.
Changes in body fat may occur while you are taking this medication (e.g., increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.
This medication may cause an increase in blood fat levels (cholesterol and triglycerides). Cholesterol and triglyceride testing should be done before and occasionally during treatment with this medication. Consult your doctor or pharmacist for more information.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Kaletra Tablets (Lopinavir, Ritonavir Tablets)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Kaletra Tablets FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The following adverse reactions are discussed in greater detail in other sections of the labeling.
- QT Interval Prolongation, PR Interval Prolongation [see WARNINGS AND PRECAUTIONS]
- Drug Interactions [see WARNINGS AND PRECAUTIONS]
- Pancreatitis [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Adult Clinical Trial Experience
The safety profile of KALETRA in adults is primarily based on 1,964 HIV-1 infected patients in clinical trials.
The most common adverse reaction was diarrhea, which was generally of mild to moderate severity.
In study 730, the incidence of diarrhea of any severity during 48 weeks of therapy was 60% in patients receiving KALETRA tablets once daily compared to 57% in patients receiving KALETRA tablets twice daily. More patients receiving KALETRA tablets once daily (14, 4.2%) had ongoing diarrhea at the time of discontinuation as compared to patients receiving KALETRA tablets twice daily (6, 1.8%). In study 730, discontinuations due to any adverse reaction were 4.8% in patients receiving KALETRA tablets once daily as compared to 3% in patients receiving KALETRA tablets twice daily. In study 802, the incidence of diarrhea of any severity during 48 weeks of therapy was 50% in patients receiving KALETRA tablets once daily compared to 39% in patients receiving KALETRA tablets twice daily. Moderate or severe drug-related diarrhea occurred in 14% of patients receiving KALETRA tablets once daily as compared to 11% in patients receiving KALETRA tablets twice daily. At the time of discontinuation, 19 (6.3%) patients receiving KALETRA tablets once daily had ongoing diarrhea, as compared to 11 (3.7%) patients receiving KALETRA tablets twice daily. Discontinuations due to any adverse reaction occurred in 4.3% of patients receiving KALETRA tablets once daily compared to 7.0% in patients receiving KALETRA tablets twice daily. In study 863, discontinuations of randomized therapy due to adverse reactions were 3.4% in KALETRA-treated and 3.7% in nelfinavir-treated patients.
Treatment-emergent clinical adverse reactions of moderate or severe intensity in ≥ 2% of patients treated with combination therapy for up to 48 weeks (Studies 863 and 730) and for up to 360 weeks (Study 720) are presented in Table 4 (treatment-naïve patients); and for up to 48 weeks (Studies 888 and 802), 84 weeks (Study 957) and 144 weeks (Study 765) in Table 5 (protease inhibitor-experienced patients).
Table 4: Percentage of Adult Patients with Selected
Treatment-Emergent1 Adverse Reactions of Moderate or Severe
Intensity Reported in ≥ 2% of Adult Antiretroviral-Naïve Patients
| Study 863 (48 Weeks) | Study 720 (360 Weeks) | Study 730 (48 Weeks) | |||
| KALETRA 400/100 mg Twice Daily + d4T + 3TC (N = 326) |
Nelfinavir 750 mg Three Times Daily + d4T + 3TC (N = 327) |
KALETRA Twice Daily2 + d4T + 3TC (N = 100) |
KALETRA 800/200 mg Once Daily + TDF +FTC (N=333) |
KALETRA 400/100 mg Twice Daily + TDF +FTC (N=331) |
|
| Endocrine Disorders | |||||
| Hypogonadism | 0% | 0% | 2% | 0% | 0% |
| Gastrointestinal Disorders | |||||
| Diarrhea | 16% | 17% | 28% | 17% | 15% |
| Nausea | 7% | 5% | 16% | 7% | 5% |
| Vomiting | 2% | 2% | 6% | 3% | 4% |
| Abdominal Pain | 4% | 3% | 11% | 1% | 1% |
| Dyspepsia | 2% | < 1% | 6% | 0% | 0% |
| Flatulence | 2% | 1% | 4% | 1% | 1% |
| General Disorders and Administration Site Conditions | |||||
| Asthenia | 4% | 3% | 9% | < 1% | < 1% |
| Infections and Infestations | |||||
| Bronchitis | 0% | 0% | 2% | 0% | < 1% |
| Investigations | |||||
| Weight Decreased | 1% | < 1% | 2% | 0% | < 1% |
| Metabolism and Nutrition Disorders | |||||
| Anorexia | 1% | < 1% | 2% | < 1% | 1% |
| Musculoskeletal and Connective Tissue Disorders | |||||
| Myalgia | 1% | 1% | 2% | 0% | 0% |
| Nervous System Disorders | |||||
| Headache | 2% | 2% | 6% | 2% | 2% |
| Paresthesia | 1% | 1% | 2% | 0% | 0% |
| Psychiatric Disorders | |||||
| Insomnia | 2% | 1% | 3% | 1% | 0% |
| Depression | 1% | 2% | 0% | 0% | 0% |
| Libido Decreased | < 1% | < 1% | 2% | 0% | < 1% |
| Skin and Subcutaneous Tissue Disorders | |||||
| Rash | 1% | 2% | 5% | < 1% | 1% |
| Vascular Disorders | |||||
| Vasodilation | 0% | 0% | 3% | 0% | 0% |
| 1 Includes adverse reactions of possible or
probable relationship to study drug. 2 Includes adverse reaction data from dose group I (200/100 mg twice daily [N = 16] and 400/100 mg twice daily [N = 16]) and dose group II (400/100 mg twice daily [N = 35] and 400/200 mg twice daily [N = 33]). Within dosing groups, moderate to severe nausea of probable/possible relationship to KALETRA occurred at a higher rate in the 400/200 mg dose arm compared to the 400/100 mg dose arm in group II. Definitions: d4T = Stavudine; 3TC = Lamivudine; TDF = Tenofovir Disoproxil Fumarate; FTC = Emtricitabine |
|||||
Table 5: Percentage of Adult
Patients with Selected Treatment-Emergent1 Adverse Reactions of
Moderate or Severe Intensity Reported in ≥ 2% of Adult Protease
Inhibitor-Experienced Patients
| Study 888 (48 Weeks) | Study 9572 and Study 7653 (84-144 Weeks) | Study 802 (48 Weeks) | |||
| KALETRA 400/100 mg Twice Daily + NVP + NRTIs (N = 148) |
Investigator-Selected Protease Inhibitor(s) + NVP + NRTIs (N = 140) |
KALETRA Twice Daily + NNRTI + NRTIs (N = 127) |
KALETRA 800/200 mg Once Daily +NRTIs (N=300) |
KALETRA 400/100 mg Twice Daily + NRTIs (N=299) |
|
| Gastrointestinal Disorders | |||||
| Diarrhea | 7% | 9% | 23% | 14% | 11% |
| Nausea | 7% | 16% | 5% | 3% | 7% |
| Vomiting | 4% | 12% | 2% | 2% | 3% |
| Abdominal Pain | 2% | 2% | 4% | 2% | < 1% |
| Abdominal Pain Upper | N/A | N/A | N/A | 1% | 2% |
| Dyspepsia | 1% | 1% | 2% | 1% | < 1% |
| Flatulence | 1% | 2% | 2% | 1% | 1% |
| Dysphasia | 2% | 1% | 0% | 0% | 0% |
| General Disorders and Administration Site Conditions | |||||
| Asthenia | 3% | 6% | 9% | < 1% | < 1% |
| Pyrexia | 2% | 1% | 2% | 0% | < 1% |
| Chills | 2% | 0% | 0% | 0% | 0% |
| Investigations | |||||
| Weight Decreased | 0% | 1% | 3% | < 1% | < 1% |
| Metabolism and Nutrition Disorders | |||||
| Anorexia | 1% | 3% | 0% | 0% | 1% |
| Musculoskeletal and Connective Tissue Disorders | |||||
| Myalgia | 1% | 1% | 2% | 0% | 0% |
| Nervous System Disorders | |||||
| Headache | 2% | 3% | 2% | < 1% | 0% |
| Paresthesia | 0% | 1% | 2% | 0% | 0% |
| Psychiatric Disorders | |||||
| Depression | 1% | 2% | 3% | < 1% | 0% |
| Insomnia | 0% | 2% | 2% | 0% | < 1% |
| Skin and Subcutaneous Tissue Disorders | |||||
| Rash | 2% | 1% | 2% | 0% | 0% |
| Vascular Disorders | |||||
| Hypertension | 0% | 0% | 2% | 0% | 0% |
| 1 Includes adverse reactions of possible or
probable relationship to study drug. 2 Includes adverse reaction data from patients receiving 400/100 mg twice daily (n = 29) or 533/133 mg twice daily (n = 28) for 84 weeks. Patients received KALETRA in combination with NRTIs and efavirenz. 3 Includes adverse reaction data from patients receiving 400/100 mg twice daily (n = 36) or 400/200 mg twice daily (n = 34) for 144 weeks. Patients received KALETRA in combination with NRTIs and nevirapine. Definitions: NVP = Nevirapine; NRTI = Nucleoside Reverse Transcriptase Inhibitors; NNRTI = Non-nucleoside Reverse Transcriptase Inhibitors |
|||||
Less Common Adverse Reactions
Treatment-emergent adverse reactions occurring in less than 2% of adult patients receiving KALETRA in the clinical trials supporting approval and of at least moderate intensity are listed below by system organ class.
Blood and Lymphatic System Disorders
Anemia, leukopenia, lymphadenopathy, neutropenia, and splenomegaly.
Cardiac Disorders
Angina pectoris, atrial fibrillation, atrioventricular block, myocardial infarction, palpitations, and tricuspid valve incompetence.
Ear and Labyrinth Disorders
Hyperacusis, tinnitus, and vertigo.
Endocrine Disorders
Cushing's syndrome and hypothyroidism.
Eye Disorders
Eye disorder and visual disturbance.
Gastrointestinal Disorders
Abdominal discomfort, abdominal distension, abdomen pain lower, constipation, duodenitis, dry mouth, enteritis, enterocolitis, enterocolitis hemorrhagic, eructation, esophagitis, fecal incontinence, gastric disorder, gastric ulcer, gastritis, gastroesophageal reflux disease, hemorrhoids, mouth ulceration, pancreatitis, periodontitis, rectal hemorrhage, stomach discomfort, and stomatitis.
General Disorders and Administration Site Conditions
Chest pain, cyst, drug interaction, edema, edema peripheral, face edema, fatigue, hypertrophy, and malaise.
Hepatobiliary Disorders
Cholangitis, cholecystitis, cytolytic hepatitis, hepatic steatosis, hepatitis, hepatomegaly, jaundice, and liver tenderness.
Immune System Disorders
Drug hypersensitivity, hypersensitivity, and immune reconstitution syndrome.
Infections and Infestations
Bacterial infection, bronchopneumonia, cellulitis, folliculitis, furuncle, gastroenteritis, influenza, otitis media, perineal abscess, pharyngitis, rhinitis, sialoadenitis, sinusitis, and viral infection.
Investigations
Drug level increased, glucose tolerance decreased, and weight increased.
Metabolism and Nutrition Disorders
Decreased appetite, dehydration, diabetes mellitus, hypovitaminosis, increased appetite, lactic acidosis, lipomatosis, and obesity.
Musculoskeletal and Connective Tissue Disorders
Arthralgia, arthropathy, back pain, muscular weakness, osteoarthritis, osteonecrosis, and pain in extremity.
Neoplasms Benign, Malignant and Unspecified (incl Cysts and Polyps)
Benign neoplasm of skin, lipoma, and neoplasm.
Nervous System Disorders
Ageusia, amnesia, ataxia, balance disorder, cerebral infarction, convulsion, dizziness, dysgeusia, dyskinesia, encephalopathy, extrapyramidal disorder, facial palsy, hypertonia, migraine, neuropathy, neuropathy peripheral, somnolence, and tremor.
Psychiatric Disorders
Abnormal dreams, affect lability, agitation, anxiety, apathy, confusional state, disorientation, mood swings, nervousness, and thinking abnormal.
Renal and Urinary Disorders
Hematuria, nephritis, nephrolithiasis, renal disorder, urine abnormality, and urine odor abnormal.
Reproductive System and Breast Disorders
Breast enlargement, ejaculation disorder, erectile dysfunction, gynecomastia, and menorrhagia.
Respiratory, Thoracic and Mediastinal Disorders
Asthma, cough, dyspnea, and pulmonary edema.
Skin and Subcutaneous Tissue Disorders
Acne, alopecia, dermatitis acneiform, dermatitis allergic, dermatitis exfoliative, dry skin, eczema, hyperhidrosis, idiopathic capillaritis, nail disorder, pruritis, rash generalized, rash maculo-papular, seborrhea, skin discoloration, skin hypertrophy, skin striae, skin ulcer, and swelling face.
Vascular Disorders
Deep vein thrombosis, orthostatic hypotension, thrombophlebitis, varicose vein, and vasculitis.
Laboratory Abnormalities
The percentages of adult patients treated with combination therapy with Grade 3-4 laboratory abnormalities are presented in Table 6 (treatment-naïve patients) and Table 7 (treatmentexperienced patients).
Table 6: Grade 3-4 Laboratory Abnormalities Reported
in ≥ 2% of Adult Antiretroviral-Naïve Patients
| Variable | Limit1 | Study 863 (48 Weeks) | Study 720 (360 Weeks) | Study 730 (48 Weeks) | ||
| KALETRA 400/100 mg Twice Daily + d4T +3TC (N = 326) |
Nelfinavir 750 mg Three Times Daily + d4T + 3TC (N = 327) |
KALETRA Twice Daily + d4T + 3TC (N = 100) |
KALETRA Once Daily + TDF +FTC (N=333) |
KALETRA Twice Daily + TDF +FTC (N=331) |
||
| Chemistry | High | |||||
| Glucose | > 250 mg/dL | 2% | 2% | 4% | 0% | < 1% |
| Uric Acid | > 12 mg/dL | 2% | 2% | 5% | < 1% | 1% |
| SGOT/ AST2 | > 180 U/L | 2% | 4% | 10% | 1% | 2% |
| SGPT/ ALT2 | > 215 U/L | 4% | 4% | 11% | 1% | 1% |
| GGT | > 300 U/L | N/A | N/A | 10% | N/A | N/A |
| Total Cholesterol | > 300 mg/dL | 9% | 5% | 27% | 4% | 3% |
| Triglycerides | > 750 mg/dL | 9% | 1% | 29% | 3% | 6% |
| Amylase | > 2 x ULN | 3% | 2% | 4% | N/A | N/A |
| Lipase | > 2 x ULN | N/A | N/A | N/A | 3% | 5% |
| Chemistry | Low | |||||
| Calculated Creatinine Clearance | < 50 mL/min | N/A | N/A | N/A | 2% | 2% |
| Hematology | Low | |||||
| Neutrophils | < 0.75 x 109/L | 1% | 3% | 5% | 2% | 1% |
| 1 ULN = upper limit of the normal range; N/A = Not Applicable. 2 Criterion for Study 730 was > 5x ULN (AST/ALT). | ||||||
Table 7: Grade 3-4
Laboratory Abnormalities Reported in ≥ 2% of Adult Protease
Inhibitor-Experienced Patients
| Variable | Limit1 | Study 888 (48 Weeks) | Study 9572 and Study 7653 (84-144 Weeks) | Study 802 (48 Weeks) | ||
| KALETRA 400/100 mg Twice Daily + NVP + NRTIs (N = 148) |
Investigator-Selected Protease Inhibitor(s) + NVP + NRTIs (N = 140) |
KALETRA Twice Daily + NNRTI + NRTIs (N = 127) |
KALETRA 800/200 mg Once Daily +NRTIs (N=300) |
KALETRA 400/100 mg Twice Daily +NRTIs (N=299) |
||
| Chemistry | High | |||||
| Glucose | > 250 mg/dL | 1% | 2% | 5% | 2% | 2% |
| Total Bilirubin | > 3.48 mg/dL | 1% | 3% | 1% | 1% | 1% |
| SGOT/AST4 | > 180 U/L | 5% | 11% | 8% | 3% | 2% |
| SGPT/ALT4 | > 215 U/L | 6% | 13% | 10% | 2% | 2% |
| GGT | > 300 U/L | N/A | N/A | 29% | N/A | N/A |
| Total Cholesterol | > 300 mg/dL | 20% | 21% | 39% | 6% | 7% |
| Triglycerides | > 750 mg/dL | 25% | 21% | 36% | 5% | 6% |
| Amylase | > 2 x ULN | 4% | 8% | 8% | 4% | 4% |
| Lipase | > 2 x ULN | N/A | N/A | N/A | 4% | 1% |
| Creatine Phosphokinase | > 4 x ULN | N/A | N/A | N/A | 4% | 5% |
| Chemistry | Low | |||||
| Calculated Creatinine Clearance | < 50 mL/min | N/A | N/A | N/A | 3% | 3% |
| Inorganic Phosphorus | < 1.5 mg/dL | 1% | 0% | 2% | 1% | < 1% |
| Hematology | Low | |||||
| Neutrophils | < 0.75 x 109/L | 1% | 2% | 4% | 3% | 4% |
| Hemoglobin | < 80 g/L | 1% | 1% | 1% | 1% | 2% |
| 1 ULN = upper limit of the normal range; N/A =
Not Applicable. 2 Includes clinical laboratory data from patients receiving 400/100 mg twice daily (n = 29) or 533/133 mg twice daily (n = 28) for 84 weeks. Patients received KALETRA in combination with NRTIs and efavirenz. 3 Includes clinical laboratory data from patients receiving 400/100 mg twice daily (n = 36) or 400/200 mg twice daily (n = 34) for 144 weeks. Patients received KALETRA in combination with NRTIs and nevirapine. 4 Criterion for Study 802 was > 5x ULN (AST/ALT). |
||||||
Pediatric Clinical Trial Experience
KALETRA Oral Solution dosed up to 300/75 mg/m² has been studied in 100 pediatric patients 6 months to 12 years of age. The adverse reaction profile seen during Study 940 was similar to that for adult patients.
Dysgeusia (22%), vomiting (21%), and diarrhea (12%) were the most common adverse reactions of any severity reported in pediatric patients treated with combination therapy for up to 48 weeks in Study 940. A total of 8 patients experienced adverse reactions of moderate to severe intensity. The adverse reactions meeting these criteria and reported for the 8 subjects include: hypersensitivity (characterized by fever, rash and jaundice), pyrexia, viral infection, constipation, hepatomegaly, pancreatitis, vomiting, alanine aminotransferase increased, dry skin, rash, and dysgeusia. Rash was the only event of those listed that occurred in 2 or more subjects (N = 3).
KALETRA Oral Solution dosed at 300/75 mg/m² has been studied in 31 pediatric patients 14 days to 6 months of age. The adverse reaction profile in Study 1030 was similar to that observed in older children and adults. No adverse reaction was reported in greater than 10% of subjects. Adverse drug reactions of moderate to severe intensity occurring in 2 or more subjects included decreased neutrophil count (N=3), anemia (N=2), high potassium (N=2), and low sodium (N=2).
KALETRA Oral Solution and soft gelatin capsules dosed at higher than recommended doses including 400/100 mg/m² (without concomitant NNRTI) and 480/120 mg/m² (with concomitant NNRTI) have been studied in 26 pediatric patients 7 to 18 years of age in Study 1038. Patients also had saquinavir mesylate added to their regimen at Week 4. Rash (12%), blood cholesterol abnormal (12%) and blood triglycerides abnormal (12%) were the only adverse reactions reported in greater than 10% of subjects. Adverse drug reactions of moderate to severe intensity occurring in 2 or more subjects included rash (N=3), blood triglycerides abnormal (N=3), and electrocardiogram QT prolonged (N=2). Both subjects with QT prolongation had additional predisposing conditions such as electrolyte abnormalities, concomitant medications, or preexisting cardiac abnormalities.
Laboratory Abnormalities
The percentages of pediatric patients treated with combination therapy including KALETRA with Grade 3-4 laboratory abnormalities are presented in Table 8.
Table 8: Grade 3-4
Laboratory Abnormalities Reported in ≥ 2% Pediatric Patients in Study 940
| Variable | Limit1 | KALETRA Twice Daily + RTIs (N = 100) |
| Chemistry | High | |
| Sodium | > 149 mEq/L | 3% |
| Total Bilirubin | ≥ 3.0 x ULN | 3% |
| SGOT/AST | > 180 U/L | 8% |
| SGPT/ALT | > 215 U/L | 7% |
| Total Cholesterol | > 300 mg/dL | 3% |
| Amylase | > 2.5 x ULN | 7%2 |
| Chemistry | Low | |
| Sodium | < 130 mEq/L | 3% |
| Hematology | Low | |
| Platelet Count | < 50 x 109/L | 4% |
| Neutrophils | < 0.40 x 109/L | 2% |
| 1 ULN = upper limit of the normal range. 2 Subjects with Grade 3-4 amylase confirmed by elevations in pancreatic amylase. |
||
Postmarketing Experience
The following adverse reactions have been reported during postmarketing use of KALETRA. Because these reactions are reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or establish a causal relationship to KALETRA exposure.
Body as a Whole
Redistribution/accumulation of body fat has been reported [see WARNINGS AND PRECAUTIONS].
Cardiovascular
Bradyarrhythmias. First-degree AV block, second-degree AV block, third-degree AV block, QTc interval prolongation, torsades (torsade) de pointes [see WARNINGS AND PRECAUTIONS].
Skin and Appendages
Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome and erythema multiforme.
Read the entire FDA prescribing information for Kaletra Tablets (Lopinavir, Ritonavir Tablets) »
Additional Kaletra Tablets Information
Kaletra Capsules - User Reviews
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