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Kaletra Tablets

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Kaletra Tablets

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

SIDE EFFECTS: Diarrhea, nausea, vomiting, stomach upset, gas, headache, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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 right away if you have any serious side effects, including: increased thirst, increased urination, confusion, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine.

Get medical help right away if you have any very serious side effects, including: 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 (such as 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 treatment with your doctor, as well as the possible use 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 rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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.

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

Treatment-Emergent Adverse Reactions

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 4):

Table 4: Treatment-Emergent 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
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
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 CONDITIONS
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
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
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

The percentages of adult patients treated with combination therapy with Grade 3-4 laboratory abnormalities are presented in Table 5 (treatment-na´ve patients) and Table 6 (treatment-experienced patients).

Table 5: Grade 3-4 Laboratory Abnormalities Reported in ≥ 2% of Adult Antiretroviral-Na´ve 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 6: 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 pre-existing 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 7.

Table 7: 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) »

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Kaletra Capsules - User Reviews

Kaletra Capsules User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Kaletra Capsules sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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