Kaletra Side Effects
Please note - some side effects for Kaletra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Kaletra - for the consumer
Kaletra
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Kaletra:
Seek medical attention right away if any of these SEVERE side effects occur when using Kaletra:Diarrhea; headache; nausea; stomach pain; tiredness; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; fever, chills, or sore throat; pale stools; severe or persistent nausea or stomach pain; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; confusion; unusual drowsiness; flushed face; fruit-like breath odor); vomiting; yellowing of the skin or eyes.
Kaletra Capsules
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Kaletra Capsules:
Seek medical attention right away if any of these SEVERE side effects occur when using Kaletra Capsules:Abnormal stools; chills; depression; diarrhea; fever; gas; headache; indigestion; loss of appetite; muscle pain; nausea; pain; prickling or tingling sensation on the skin; shift in body fat to stomach and upper body; sleeplessness; stomach pain; tiredness; vomiting; weakness; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in stools; dark urine; drowsiness; fatigue; flushed face; increased blood sugar; increased thirst or urination; persistent fever; severe stomach pain with nausea and vomiting; unusual bleeding or bruising; unusual hunger; vision changes; yellowing of the skin or eyes.
Kaletra Solution
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Kaletra Solution:
Seek medical attention right away if any of these SEVERE side effects occur when using Kaletra Solution:Diarrhea; headache; nausea; stomach pain; tiredness; weakness.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; fever, chills, or sore throat; pale stools; severe or persistent nausea or stomach pain; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; confusion; unusual drowsiness; flushed face; fruit-like breath odor); vomiting; yellowing of the skin or eyes.
For the professional
Kaletra
Adults
Treatment-Emergent Adverse EventsKaletra has been studied in 891 patients as combination therapy in Phase I/II and Phase III clinical trials. The most common adverse event associated with Kaletra therapy was diarrhea, which was generally of mild to moderate severity. Rates of discontinuation of randomized therapy due to adverse events were 5.8% in Kaletra-treated and 4.9% in nelfinavir-treated patients in Study 863. The incidence of diarrhea was greater for Kaletra once-daily compared to Kaletra twice-daily in Study 418.
Drug related clinical adverse events of moderate or severe intensity in ≥ 2% of patients treated with combination therapy for up to 48 weeks (Phase III) and for up to 204 weeks (Phase I/II) are presented in Table 11. For other information regarding observed or potentially serious adverse events, please see WARNINGS and PRECAUTIONS.
|
Study 863 (48 Weeks) |
Study 418 (48 Weeks) |
Study 720 (204 Weeks) |
|||
|
Kaletra 400/100 mg BID + d4T
+ 3TC (N=326) |
Nelfinavir 750 mg TID + d4T +
3TC (N=327) |
Kaletra 800/200 mg QD + TDF +
FTC (N=115) |
Kaletra 400/100 mg BID + TDF
+ FTC (N=75) |
Kaletra BID2 + d4T
+ 3TC (N=100) |
|
|
1 Includes adverse events of possible, probable, or unknown relationship to study drug. 2 Includes adverse event data from dose group I (200/100 mg BID [N=16] and 400/100 mg BID [N=16]) and dose group II (400/100 mg BID [N=35] and 400/200 mg BID [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. | |||||
| Body as a Whole | |||||
| Abdominal Pain |
4% | 3% | 3% | 3% | 10% |
| Asthenia | 4% | 3% | 0% | 0% | 9% |
| Headache | 2% | 2% | 3% | 3% | 7% |
| Cardiovascular System | |||||
| Vein distended | 0% | 0% | 0% | 0% | 2% |
| Digestive System | |||||
| Anorexia | 1% | <1% | <1% | 1% | 2% |
| Diarrhea | 16% | 17% | 16% | 5% | 27% |
| Dyspepsia | 2% | <1% | 0% | 1% | 5% |
| Flatulence | 2% | 1% | 2% | 1% | 4% |
| Nausea | 7% | 5% | 9% | 8% | 16% |
| Vomiting | 2% | 2% | 3% | 4% | 6% |
| Metabolic and Nutritional | |||||
| Weight Loss | 1% | <1% | 0% | 0% | 2% |
| Musculoskeletal | |||||
| Myalgia | 1% | 1% | 0% | 0% | 2% |
| Nervous System | |||||
| Depression | 1% | 2% | 1% | 0% | 0% |
| Insomnia | 2% | 1% | 0% | 0% | 2% |
| Libido decreased |
<1% | <1% | 0% | 1% | 2% |
| Paresthesia | 1% | 1% | 0% | 0% | 2% |
| Respiratory | |||||
| Bronchitis | 0% | 0% | 0% | 0% | 2% |
| Skin and Appendages | |||||
| Rash | 1% | 2% | 1% | 0% | 4% |
| Urogenital | |||||
| Hypogonadism male |
0% | 0% | 0% | 0% | 2% |
| Study 888 (48 Weeks) | Study 9572 and Study 7653 (84-144 Weeks) | ||
|
Kaletra 400/100 mg
BID + NVP + NRTIs (N=148) |
Investigator-selected
protease inhibitor(s) + NVP + NRTIs (N=140) |
Kaletra BID +
NNRTI + NRTIs (N=127) |
|
|
1 Includes adverse events of possible, probable, or unknown relationship to study drug. 2 Includes adverse event data from patients receiving 400/100 mg BID (n=29) or 533/133 mg BID (n=28) for 84 weeks. Patients receiving Kaletra in combination with NRTIs and efavirenz. 3 Includes adverse event data from patients receiving 400/100 mg BID (n=36) or 400/200 mg BID (n=34) for 144 weeks. Patients received Kaletra in combination with NRTIs and nevirapine. | |||
| Body as a Whole | |||
| Abdominal Pain | 2% | 2% | 4% |
| Asthenia | 3% | 6% | 9% |
| Chills | 2% | 0% | 0% |
| Fever | 2% | 1% | 2% |
| Headache | 2% | 3% | 2% |
| Cardiovascular | |||
| Hypertension | 0% | 0% | 2% |
| Digestive System | |||
| Anorexia | 1% | 3% | 0% |
| Diarrhea | 7% | 9% | 23% |
| Dyspepsia | 1% | 1% | 2% |
| Dysphagia | 2% | 1% | 0% |
| Flatulence | 1% | 2% | 2% |
| Nausea | 7% | 16% | 5% |
| Vomiting | 4% | 12% | 2% |
| Metabolic and Nutritional | |||
| Weight loss | 0% | 1% | 3% |
| Musculoskeletal | |||
| Myalgia | 1% | 1% | 2% |
| Nervous System | |||
| Depression | 1% | 2% | 2% |
| Insomnia | 0% | 2% | 2% |
| Paresthesia | 1% | 0% | 2% |
| Skin and Appendages | |||
| Rash | 2% | 1% | 2% |
Treatment-emergent adverse events occurring in less than 2% of adult patients receiving Kaletra in all phase II/III clinical trials and considered at least possibly related or of unknown relationship to treatment with Kaletra and of at least moderate intensity are listed below by body system.
Body as a Whole
Allergic reaction, back pain, chest pain, chest pain substernal, cyst, drug interaction, drug level increased, face edema, flu syndrome, hypertrophy, infection bacterial, malaise, and viral infection.
Cardiovascular System
Atrial fibrillation, cerebral infarct, deep thrombophlebitis, deep vein thrombosis, migraine, palpitation, postural hypotension, thrombophlebitis, varicose vein, and vasculitis.
Digestive System
Cholangitis, cholecystitis, constipation, dry mouth, enteritis, enterocolitis, eructation, esophagitis, fecal incontinence, gastritis, gastroenteritis, hemorrhagic colitis, hepatitis, increased appetite, jaundice, mouth ulceration, pancreatitis, periodontitis, sialadenitis, stomatitis, and ulcerative stomatitis.
Endocrine System
Cushing's syndrome, diabetes mellitus, and hypothyroidism.
Hemic and Lymphatic System
Anemia, leukopenia, and lymphadenopathy.
Metabolic and Nutritional Disorders
Avitaminosis, dehydration, edema, glucose tolerance decreased, lactic acidosis, obesity, peripheral edema, and weight gain.
Musculoskeletal System
Arthralgia, arthrosis and bone necrosis.
Nervous System
Abnormal dreams, agitation, amnesia, anxiety, apathy, ataxia, confusion, convulsion, dizziness, dyskinesia, emotional lability, encephalopathy, facial paralysis, hypertonia, nervousness, neuropathy, peripheral neuritis, somnolence, thinking abnormal, tremor, and vertigo.
Respiratory System
Asthma, dyspnea, lung edema, pharyngitis, rhinitis, and sinusitis.
Skin and Appendages
Acne, alopecia, dry skin, eczema, exfoliative dermatitis, furunculosis, maculopapular rash, nail disorder, pruritis, seborrhea, skin benign neoplasm, skin discoloration, skin ulcer, and sweating.
Special Senses
Abnormal vision, eye disorder, otitis media, taste loss, taste perversion, and tinnitus.
Urogenital System
Abnormal ejaculation, amenorrhea, breast enlargement, gynecomastia, kidney calculus, nephritis, and urine abnormality.
Post-marketing ExperienceThe following adverse reactions have been reported during post-marketing 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.
Cardiovascular
Bradyarrhythmias.
Skin and Appendages
Stevens Johnson Syndrome and erythema multiforme.
Laboratory AbnormalitiesThe percentages of adult patients treated with combination therapy with Grade 3-4 laboratory abnormalities are presented in Table 13 and Table 14.
| Study 863 (48 Weeks) | Study 418 (48 Weeks) | Study 720 (204 Weeks) | ||||
| Variable | Limit1 | Kaletra 400/100
mg BID + d4T +3TC (N=326) |
Nelfinavir 750
mg TID + d4T + 3TC (N=327) |
Kaletra 800/200
mg QD + TDF + FTC (N=115) |
Kaletra 400/100
mg BID + TDF + FTC (N=75) |
Kaletra BID +
d4T + 3TC (N=100) |
1 ULN = upper limit of the normal range; N/A = Not Applicable. | ||||||
| Chemistry | High | |||||
| Glucose | >250 mg/dL | 2% | 2% | 3% | 1% | 4% |
| Uric Acid | >12 mg/dL | 2% | 2% | 0% | 3% | 3% |
| SGOT/ AST |
>180 U/L | 2% | 4% | 5% | 3% | 9% |
| SGPT/ ALT |
>215 U/L | 4% | 4% | 4% | 3% | 9% |
| GGT | >300 U/L | N/A | N/A | N/A | N/A | 6% |
| Total Cholesterol |
>300 mg/dL | 9% | 5% | 3% | 3% | 22% |
| Triglycerides | >750 mg/dL | 9% | 1% | 5% | 4% | 22% |
| Amylase | >2 x ULN | 3% | 2% | 7% | 5% | 4% |
| Hematology | Low | |||||
| Neutrophils | 0.75 x 109/L | 1% | 3% | 5% | 1% | 5% |
| Study 888 (48 Weeks) | Study 9572 and Study 7653 (84-144 Weeks) | |||
| Variable | Limit1 | Kaletra
400/100 mg BID + NVP + NRTIs (N=148) |
Investigator-selected
protease inhibitor(s) + NVP + NRTIs (N=140) |
Kaletra
BID + NNRTI + NRTIs (N=127) |
|
1 ULN = upper limit of the normal range; N/A = Not Applicable. 2 Includes clinical laboratory data from patients receiving 400/100 mg BID (n=29) or 533/133 mg BID (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 BID (n=36) or 400/200 mg BID (n=34) for 144 weeks. Patients received Kaletra in combination with NRTIs and nevirapine. | ||||
| Chemistry | High | |||
| Glucose | >250 mg/dL | 1% | 2% | 5% |
| Total Bilirubin | >3.48 mg/dL | 1% | 3% | 1% |
| SGOT/AST | >180 U/L | 5% | 11% | 8% |
| SGPT/ALT | >215 U/L | 6% | 13% | 10% |
| GGT | >300 U/L | N/A | N/A | 29% |
| Total Cholesterol |
>300 mg/dL | 20% | 21% | 39% |
| Triglycerides | >750 mg/dL | 25% | 21% | 36% |
| Amylase | >2 x ULN | 4% | 8% | 8% |
| Chemistry | Low | |||
| Inorganic Phosphorus |
<1.5 mg/dL | 1% | 0% | 2% |
| Hematology | Low | |||
| Neutrophils | 0.75 x 109/L | 1% | 2% | 4% |
Pediatrics
Treatment-Emergent Adverse EventsKaletra has been studied in 100 pediatric patients 6 months to 12 years of age. The adverse event profile seen during a clinical trial was similar to that for adult patients.
Taste aversion, vomiting, and diarrhea were the most commonly reported drug related adverse events of any severity in pediatric patients treated with combination therapy including Kaletra for up to 48 weeks in Study 940. A total of 8 children experienced moderate or severe adverse events at least possibly related to Kaletra. Rash (reported in 3%) was the only drug-related clinical adverse event of moderate to severe intensity observed in ≥ 2% of children enrolled.
Laboratory AbnormalitiesThe percentages of pediatric patients treated with combination therapy including Kaletra with Grade 3-4 laboratory abnormalities are presented in Table 15.
| Variable | Limit1 | Kaletra BID+ RTIs (N = 100) |
|
1 ULN = upper limit of the normal range. 2 Subjects with Grade 3-4 amylase confirmed by elevations in pancreatic amylase. | ||
| 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% |
Kaletra Oral Solution
Adults
Treatment-Emergent Adverse EventsKaletra has been studied in 891 patients as combination therapy in Phase I/II and Phase III clinical trials. The most common adverse event associated with Kaletra therapy was diarrhea, which was generally of mild to moderate severity. Rates of discontinuation of randomized therapy due to adverse events were 5.8% in Kaletra-treated and 4.9% in nelfinavir-treated patients in Study 863. The incidence of diarrhea was greater for Kaletra once-daily compared to Kaletra twice-daily in Study 418.
Drug related clinical adverse events of moderate or severe intensity in ≥ 2% of patients treated with combination therapy for up to 48 weeks (Phase III) and for up to 204 weeks (Phase I/II) are presented in Table 11. For other information regarding observed or potentially serious adverse events, please see WARNINGS and PRECAUTIONS.
|
Study 863 (48 Weeks) |
Study 418 (48 Weeks) |
Study 720 (204 Weeks) |
|||
|
Kaletra 400/100 mg BID + d4T
+ 3TC (N=326) |
Nelfinavir 750 mg TID + d4T +
3TC (N=327) |
Kaletra 800/200 mg QD + TDF +
FTC (N=115) |
Kaletra 400/100 mg BID + TDF
+ FTC (N=75) |
Kaletra BID2 + d4T
+ 3TC (N=100) |
|
|
1 Includes adverse events of possible, probable, or unknown relationship to study drug. 2 Includes adverse event data from dose group I (200/100 mg BID [N=16] and 400/100 mg BID [N=16]) and dose group II (400/100 mg BID [N=35] and 400/200 mg BID [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. | |||||
| Body as a Whole | |||||
| Abdominal Pain |
4% | 3% | 3% | 3% | 10% |
| Asthenia | 4% | 3% | 0% | 0% | 9% |
| Headache | 2% | 2% | 3% | 3% | 7% |
| Cardiovascular System | |||||
| Vein distended | 0% | 0% | 0% | 0% | 2% |
| Digestive System | |||||
| Anorexia | 1% | <1% | <1% | 1% | 2% |
| Diarrhea | 16% | 17% | 16% | 5% | 27% |
| Dyspepsia | 2% | <1% | 0% | 1% | 5% |
| Flatulence | 2% | 1% | 2% | 1% | 4% |
| Nausea | 7% | 5% | 9% | 8% | 16% |
| Vomiting | 2% | 2% | 3% | 4% | 6% |
| Metabolic and Nutritional | |||||
| Weight Loss | 1% | <1% | 0% | 0% | 2% |
| Musculoskeletal | |||||
| Myalgia | 1% | 1% | 0% | 0% | 2% |
| Nervous System | |||||
| Depression | 1% | 2% | 1% | 0% | 0% |
| Insomnia | 2% | 1% | 0% | 0% | 2% |
| Libido decreased |
<1% | <1% | 0% | 1% | 2% |
| Paresthesia | 1% | 1% | 0% | 0% | 2% |
| Respiratory | |||||
| Bronchitis | 0% | 0% | 0% | 0% | 2% |
| Skin and Appendages | |||||
| Rash | 1% | 2% | 1% | 0% | 4% |
| Urogenital | |||||
| Hypogonadism male |
0% | 0% | 0% | 0% | 2% |
| Study 888 (48 Weeks) | Study 9572 and Study 7653 (84-144 Weeks) | ||
|
Kaletra 400/100 mg
BID + NVP + NRTIs (N=148) |
Investigator-selected
protease inhibitor(s) + NVP + NRTIs (N=140) |
Kaletra BID +
NNRTI + NRTIs (N=127) |
|
|
1 Includes adverse events of possible, probable, or unknown relationship to study drug. 2 Includes adverse event data from patients receiving 400/100 mg BID (n=29) or 533/133 mg BID (n=28) for 84 weeks. Patients receiving Kaletra in combination with NRTIs and efavirenz. 3 Includes adverse event data from patients receiving 400/100 mg BID (n=36) or 400/200 mg BID (n=34) for 144 weeks. Patients received Kaletra in combination with NRTIs and nevirapine. | |||
| Body as a Whole | |||
| Abdominal Pain | 2% | 2% | 4% |
| Asthenia | 3% | 6% | 9% |
| Chills | 2% | 0% | 0% |
| Fever | 2% | 1% | 2% |
| Headache | 2% | 3% | 2% |
| Cardiovascular | |||
| Hypertension | 0% | 0% | 2% |
| Digestive System | |||
| Anorexia | 1% | 3% | 0% |
| Diarrhea | 7% | 9% | 23% |
| Dyspepsia | 1% | 1% | 2% |
| Dysphagia | 2% | 1% | 0% |
| Flatulence | 1% | 2% | 2% |
| Nausea | 7% | 16% | 5% |
| Vomiting | 4% | 12% | 2% |
| Metabolic and Nutritional | |||
| Weight loss | 0% | 1% | 3% |
| Musculoskeletal | |||
| Myalgia | 1% | 1% | 2% |
| Nervous System | |||
| Depression | 1% | 2% | 2% |
| Insomnia | 0% | 2% | 2% |
| Paresthesia | 1% | 0% | 2% |
| Skin and Appendages | |||
| Rash | 2% | 1% | 2% |
Treatment-emergent adverse events occurring in less than 2% of adult patients receiving Kaletra in all phase II/III clinical trials and considered at least possibly related or of unknown relationship to treatment with Kaletra and of at least moderate intensity are listed below by body system.
Body as a Whole
Allergic reaction, back pain, chest pain, chest pain substernal, cyst, drug interaction, drug level increased, face edema, flu syndrome, hypertrophy, infection bacterial, malaise, and viral infection.
Cardiovascular System
Atrial fibrillation, cerebral infarct, deep thrombophlebitis, deep vein thrombosis, migraine, palpitation, postural hypotension, thrombophlebitis, varicose vein, and vasculitis.
Digestive System
Cholangitis, cholecystitis, constipation, dry mouth, enteritis, enterocolitis, eructation, esophagitis, fecal incontinence, gastritis, gastroenteritis, hemorrhagic colitis, hepatitis, increased appetite, jaundice, mouth ulceration, pancreatitis, periodontitis, sialadenitis, stomatitis, and ulcerative stomatitis.
Endocrine System
Cushing's syndrome, diabetes mellitus, and hypothyroidism.
Hemic and Lymphatic System
Anemia, leukopenia, and lymphadenopathy.
Metabolic and Nutritional Disorders
Avitaminosis, dehydration, edema, glucose tolerance decreased, lactic acidosis, obesity, peripheral edema, and weight gain.
Musculoskeletal System
Arthralgia, arthrosis and bone necrosis.
Nervous System
Abnormal dreams, agitation, amnesia, anxiety, apathy, ataxia, confusion, convulsion, dizziness, dyskinesia, emotional lability, encephalopathy, facial paralysis, hypertonia, nervousness, neuropathy, peripheral neuritis, somnolence, thinking abnormal, tremor, and vertigo.
Respiratory System
Asthma, dyspnea, lung edema, pharyngitis, rhinitis, and sinusitis.
Skin and Appendages
Acne, alopecia, dry skin, eczema, exfoliative dermatitis, furunculosis, maculopapular rash, nail disorder, pruritis, seborrhea, skin benign neoplasm, skin discoloration, skin ulcer, and sweating.
Special Senses
Abnormal vision, eye disorder, otitis media, taste loss, taste perversion, and tinnitus.
Urogenital System
Abnormal ejaculation, amenorrhea, breast enlargement, gynecomastia, kidney calculus, nephritis, and urine abnormality.
Post-marketing ExperienceThe following adverse reactions have been reported during post-marketing 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.
Cardiovascular
Bradyarrhythmias.
Skin and Appendages
Stevens Johnson Syndrome and erythema multiforme.
Laboratory AbnormalitiesThe percentages of adult patients treated with combination therapy with Grade 3-4 laboratory abnormalities are presented in Table 13 and Table 14.
| Study 863 (48 Weeks) | Study 418 (48 Weeks) | Study 720 (204 Weeks) | ||||
| Variable | Limit1 | Kaletra 400/100
mg BID + d4T +3TC (N=326) |
Nelfinavir 750
mg TID + d4T + 3TC (N=327) |
Kaletra 800/200
mg QD + TDF + FTC (N=115) |
Kaletra 400/100
mg BID + TDF + FTC (N=75) |
Kaletra BID +
d4T + 3TC (N=100) |
1 ULN = upper limit of the normal range; N/A = Not Applicable. | ||||||
| Chemistry | High | |||||
| Glucose | >250 mg/dL | 2% | 2% | 3% | 1% | 4% |
| Uric Acid | >12 mg/dL | 2% | 2% | 0% | 3% | 3% |
| SGOT/ AST |
>180 U/L | 2% | 4% | 5% | 3% | 9% |
| SGPT/ ALT |
>215 U/L | 4% | 4% | 4% | 3% | 9% |
| GGT | >300 U/L | N/A | N/A | N/A | N/A | 6% |
| Total Cholesterol |
>300 mg/dL | 9% | 5% | 3% | 3% | 22% |
| Triglycerides | >750 mg/dL | 9% | 1% | 5% | 4% | 22% |
| Amylase | >2 x ULN | 3% | 2% | 7% | 5% | 4% |
| Hematology | Low | |||||
| Neutrophils | 0.75 x 109/L | 1% | 3% | 5% | 1% | 5% |
| Study 888 (48 Weeks) | Study 9572 and Study 7653 (84-144 Weeks) | |||
| Variable | Limit1 | Kaletra
400/100 mg BID + NVP + NRTIs (N=148) |
Investigator-selected
protease inhibitor(s) + NVP + NRTIs (N=140) |
Kaletra
BID + NNRTI + NRTIs (N=127) |
|
1 ULN = upper limit of the normal range; N/A = Not Applicable. 2 Includes clinical laboratory data from patients receiving 400/100 mg BID (n=29) or 533/133 mg BID (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 BID (n=36) or 400/200 mg BID (n=34) for 144 weeks. Patients received Kaletra in combination with NRTIs and nevirapine. | ||||
| Chemistry | High | |||
| Glucose | >250 mg/dL | 1% | 2% | 5% |
| Total Bilirubin | >3.48 mg/dL | 1% | 3% | 1% |
| SGOT/AST | >180 U/L | 5% | 11% | 8% |
| SGPT/ALT | >215 U/L | 6% | 13% | 10% |
| GGT | >300 U/L | N/A | N/A | 29% |
| Total Cholesterol |
>300 mg/dL | 20% | 21% | 39% |
| Triglycerides | >750 mg/dL | 25% | 21% | 36% |
| Amylase | >2 x ULN | 4% | 8% | 8% |
| Chemistry | Low | |||
| Inorganic Phosphorus |
<1.5 mg/dL | 1% | 0% | 2% |
| Hematology | Low | |||
| Neutrophils | 0.75 x 109/L | 1% | 2% | 4% |
Pediatrics
Treatment-Emergent Adverse EventsKaletra has been studied in 100 pediatric patients 6 months to 12 years of age. The adverse event profile seen during a clinical trial was similar to that for adult patients.
Taste aversion, vomiting, and diarrhea were the most commonly reported drug related adverse events of any severity in pediatric patients treated with combination therapy including Kaletra for up to 48 weeks in Study 940. A total of 8 children experienced moderate or severe adverse events at least possibly related to Kaletra. Rash (reported in 3%) was the only drug-related clinical adverse event of moderate to severe intensity observed in ≥ 2% of children enrolled.
Laboratory AbnormalitiesThe percentages of pediatric patients treated with combination therapy including Kaletra with Grade 3-4 laboratory abnormalities are presented in Table 15.
| Variable | Limit1 | Kaletra BID+ RTIs (N = 100) |
|
1 ULN = upper limit of the normal range. 2 Subjects with Grade 3-4 amylase confirmed by elevations in pancreatic amylase. | ||
| 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% |
More resources:
Kaletra - Includes detailed dosage instructions.
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