Side Effects > Kaletra

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).

For the consumer Kaletra Kaletra Capsules Kaletra Solution For the professional Kaletra Kaletra Oral Solution

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:

Diarrhea; headache; nausea; stomach pain; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Kaletra:

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:

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Kaletra Capsules:

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:

Diarrhea; headache; nausea; stomach pain; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Kaletra Solution:

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.

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For the professional

Kaletra

Adults

Treatment-Emergent Adverse Events

Kaletra 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.

Table 11. Percentage of Patients with Selected Treatment-Emergent1 Adverse Events of Moderate or Severe Intensity Reported in ≥ 2% of Adult Antiretroviral-Naïve Patients

	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%

Table 12. Percentage of Patients with Selected Treatment-Emergent1 Adverse Events 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)
	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 Experience

The 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 Abnormalities

The percentages of adult patients treated with combination therapy with Grade 3-4 laboratory abnormalities are presented in Table 13 and Table 14.

Table 13. Grade 3-4 Laboratory Abnormalities Reported in ≥ 2% of Adult Antiretroviral-Naïve Patients

		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%

Table 14. Grade 3-4 Laboratory Abnormalities Reported in ≥ 2% of Adult Protease Inhibitor-Experienced Patients

		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 Events

Kaletra 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 Abnormalities

The percentages of pediatric patients treated with combination therapy including Kaletra with Grade 3-4 laboratory abnormalities are presented in Table 15.

Table 15. Grade 3-4 Laboratory Abnormalities Reported in ≥ 2% Pediatric Patients

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%

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Kaletra Oral Solution

Adults

Treatment-Emergent Adverse Events

Kaletra 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.

Table 11. Percentage of Patients with Selected Treatment-Emergent1 Adverse Events of Moderate or Severe Intensity Reported in ≥ 2% of Adult Antiretroviral-Naïve Patients

	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%

Table 12. Percentage of Patients with Selected Treatment-Emergent1 Adverse Events 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)
	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 Experience

The 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 Abnormalities

The percentages of adult patients treated with combination therapy with Grade 3-4 laboratory abnormalities are presented in Table 13 and Table 14.

Table 13. Grade 3-4 Laboratory Abnormalities Reported in ≥ 2% of Adult Antiretroviral-Naïve Patients

		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%

Table 14. Grade 3-4 Laboratory Abnormalities Reported in ≥ 2% of Adult Protease Inhibitor-Experienced Patients

		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 Events

Kaletra 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 Abnormalities

The percentages of pediatric patients treated with combination therapy including Kaletra with Grade 3-4 laboratory abnormalities are presented in Table 15.

Table 15. Grade 3-4 Laboratory Abnormalities Reported in ≥ 2% Pediatric Patients

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%

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