Kaletra Tablets

• Generic Name: lopinavir, ritonavir tablets
• Brand Name: Kaletra Tablets

Kaletra Tablets (Lopinavir, Ritonavir Tablets) side effects drug center

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PROFESSIONAL

CONSUMER

SIDE EFFECTS

• Overview
• Consumer Information
• Professional Information

 

Kaletra Tablets Side Effects Center

What Is Kaletra?

Kaletra (lopinavir/ritonavir) is a combination of two antiviral medications called protease inhibitors used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Kaletra is not a cure for HIV or AIDS.

What Are Side Effects of Kaletra?

Common side effects of Kaletra include:

• diarrhea,
• headache,
• weakness,
• nausea,
• vomiting,
• stomach upset,
• drowsiness,
• dizziness,
• a bad taste in the mouth,
• trouble sleeping,
• skin rash, and
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

Tell your doctor if you have serious side effects of Kaletra including:

• unexplained weight loss,
• persistent muscle aches or weakness,
• joint pain,
• numbness or tingling of the hands/feet/arms/legs,
• severe tiredness,
• vision changes,
• severe or 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 nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech),
• increased thirst,
• increased urination,
• confusion,
• persistent nausea or vomiting,
• stomach or abdominal pain,
• yellowing eyes or skin, or
• dark urine.

Dosage for Kaletra

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.

What Drugs, Substances, or Supplements Interact with Kaletra?

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 During Pregnancy and Breastfeeding

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 breastfeed.

Additional Information

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.

 

Kaletra Tablets Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• signs of a kidney stone--pain in your side or lower back, blood in your urine, painful or difficult urination;
• high blood sugar--increased thirst, increased urination, fruity breath odor, weight loss; or
• signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Lopinavir and ritonavir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Lopinavir and ritonavir liquid contains alcohol and propylene glycol, which may cause drowsiness or slow breathing in a baby taking this medicine. Tell your doctor if you notice these symptoms in your baby.

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

Common side effects may include:

• nausea, vomiting, diarrhea; or
• high cholesterol or triglycerides.

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)

 

Kaletra Tablets Professional Information

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]

Clinical Trials Experience

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.

Adverse Reactions In Adults

The safety of KALETRA has been investigated in about 2,600 patients in Phase II-IV clinical trials, of which about 700 have received a dose of 800/200 mg (6 capsules or 4 tablets) once daily. Along with nucleoside reverse transcriptase inhibitors (NRTIs), in some studies, KALETRA was used in combination with efavirenz or nevirapine.

In clinical studies the incidence of diarrhea in patients treated with either KALETRA capsules or tablets was greater in those patients treated once daily than in those patients treated twice daily. Any grade of diarrhea was reported by at least half of patients taking once daily Kaletra capsules or tablets. At the time of treatment discontinuation, 4.2-6.3% of patients taking once daily Kaletra and 1.8-3.7% of those taking twice daily Kaletra reported ongoing diarrhea.

Commonly reported adverse reactions to KALETRA included diarrhea, nausea, vomiting, hypertriglyceridemia and hypercholesterolemia. Diarrhea, nausea and vomiting may occur at the beginning of the treatment while hypertriglyceridemia and hypercholesterolemia may occur later. The following have been identified as adverse reactions of moderate or severe intensity (Table 8):

Table 8: Adverse Reactions of Moderate or Severe Intensity Occurring in at Least 0.1% of Adult Patients Receiving KALETRA in Combined Phase II/IV Studies (N=2,612)

System Organ Class (SOC) and Adverse Reaction	n	%
BLOOD AND LYMPHATIC SYSTEM DISORDERS
anemia*	54	2.1
leukopenia and neutropenia*	44	1.7
lymphadenopathy*	35	1.3
CARDIAC DISORDERS
atherosclerosis such as myocardial infarction*	10	0.4
atrioventricular block*	3	0.1
tricuspid valve incompetence*	3	0.1
EAR AND LABYRINTH DISORDERS
vertigo*	7	0.3
tinnitus	6	0.2
ENDOCRINE DISORDERS
hypogonadism*	16	0.81
EYE DISORDERS
visual impairment*	8	0.3
GASTROINTESTINAL DISORDERS
diarrhea*	510	19.5
nausea	269	10.3
vomiting*	177	6.8
abdominal pain (upper and lower)*	160	6.1
gastroenteritis and colitis*	66	2.5
dyspepsia	53	2.0
pancreatitis*	45	1.7
Gastroesophageal Reflux Disease (GERD)*	40	1.5
hemorrhoids	39	1.5
flatulence	36	1.4
abdominal distension	34	1.3
constipation*	26	1.0
stomatitis and oral ulcers*	24	0.9
duodenitis and gastritis*	20	0.8
gastrointestinal hemorrhage including rectal hemorrhage*	13	0.5
dry mouth	9	0.3
gastrointestinal ulcer*	6	0.2
fecal incontinence	5	0.2
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITION
fatigue including asthenia*	198	7.6
HEPATOBILIARY DISORDERS
hepatitis including AST, ALT, and GGT increases*	91	3.5
hepatomegaly	5	0.2
cholangitis	3	0.1
hepatic steatosis	3	0.1
IMMUNE SYSTEM DISORDERS
hypersensitivity including urticaria and angioedema*	70	2.7
immune reconstitution syndrome	3	0.1
INFECTIONS AND INFESTATIONS
upper respiratory tract infection*	363	13.9
lower respiratory tract infection*	202	7.7
skin infections including cellulitis, folliculitis, and furuncle*	86	3.3
METABOLISM AND NUTRITION DISORDERS
hypercholesterolemia*	192	7.4
hypertriglyceridemia*	161	6.2
weight decreased*	61	2.3
decreased appetite	52	2.0
blood glucose disorders including diabetes mellitus*	30	1.1
weight increased*	20	0.8
lactic acidosis*	11	0.4
increased appetite	5	0.2
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
musculoskeletal pain including arthralgia and back pain*	166	6.4
myalgia*	46	1.8
muscle disorders such as weakness and spasms*	34	1.3
rhabdomyolysis*	18	0.7
osteonecrosis	3	0.1
NERVOUS SYSTEM DISORDERS
headache including migraine*	165	6.3
insomnia*	99	3.8
neuropathy and peripheral neuropathy*	51	2.0
dizziness*	45	1.7
ageusia*	19	0.7
convulsion*	9	0.3
tremor*	9	0.3
cerebral vascular event*	6	0.2
PSYCHIATRIC DISORDERS
anxiety*	101	3.9
abnormal dreams*	19	0.7
libido decreased	19	0.7
RENAL AND URINARY DISORDERS
renal failure*	31	1.2
hematuria*	20	0.8
nephritis*	3	0.1
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
erectile dysfunction*	34	1.71
menstrual disorders - amenorrhea, menorrhagia*	10	1.72
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
rash including maculopapular rash*	99	3.8
lipodystrophy acquired including facial wasting*	58	2.2
dermatitis/rash including eczema and seborrheic dermatitis*	50	1.9
night sweats*	42	1.6
pruritus*	29	1.1
alopecia	10	0.4
capillaritis and vasculitis*	3	0.1
VASCULAR DISORDERS
hypertension*	47	1.8
deep vein thrombosis*	17	0.7
*Represents a medical concept including several similar MedDRA PTs 1. Percentage of male population (N=2,038) 2. Percentage of female population (N=574)

Laboratory Abnormalities In Adults

The percentages of adult patients treated with combination therapy with Grade 3-4 laboratory abnormalities are presented in Table 9 (treatment-naive patients) and Table 10 (treatmentexperienced patients).

Table 9: Grade 3-4 Laboratory Abnormalities Reported in ≥ 2% of Adult Antiretroviral-Naive 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	>180U/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 10: 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).

Adverse Reactions In Pediatric Patients

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 In Pediatric Patients

The percentages of pediatric patients treated with combination therapy including KALETRA with Grade 3-4 laboratory abnormalities are presented in Table 11.

Table 11: 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	>180U/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)

&Copy; Kaletra Tablets Patient Information is supplied by Cerner Multum, Inc. and Kaletra Tablets Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.