Drug: Caprelsa
Vandetanib has the chemical name N-(4-bromo-2-fluorophenyl)-6-methoxy-7-[(1-methylpiperidin-4-yl) methoxy]quinazolin-4-amine. The structural and molecular formulas are:
C22H24BrFN4O2 Vandetanib has a molecular weight of 475.36. Vandetanib exhibits pH-dependent solubility, with increased solubility at lower pH. Vandetanib is practically insoluble in water with a value of 0.008 mg/mL at 25°C (77°F ). CAPRELSA tablets for daily oral administration are available in two dosage strengths containing either 100 mg or 300 mg of vandetanib. The tablet cores contain the following inactive ingredients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, crospovidone, povidone, and magnesium stearate. The tablet film-coat contains the following inactive ingredients: hypromellose 2910, macrogol 300, and titanium dioxide E171. Last reviewed on RxList: 4/10/2014
This monograph has been modified to include the generic and brand name in many instances.
C22H24BrFN4O2 Vandetanib has a molecular weight of 475.36. Vandetanib exhibits pH-dependent solubility, with increased solubility at lower pH. Vandetanib is practically insoluble in water with a value of 0.008 mg/mL at 25°C (77°F ). CAPRELSA tablets for daily oral administration are available in two dosage strengths containing either 100 mg or 300 mg of vandetanib. The tablet cores contain the following inactive ingredients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, crospovidone, povidone, and magnesium stearate. The tablet film-coat contains the following inactive ingredients: hypromellose 2910, macrogol 300, and titanium dioxide E171. Last reviewed on RxList: 4/10/2014
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
The following serious adverse reactions are discussed elsewhere in the label:
System Organ Class Preferred Term CAPRELSA 300 mg
N=231 Placebo
N=99 All Grades (%) Grade 3-4 (%) All Grades (%) Grade 3-4 (%) Gastrointestinal Disorders Diarrhea/Colitis 57 11 27 2 Nausea 33 1 16 0 Abdominal Pain2 21 3 11 0 Vomiting 15 1 7 0 Dyspepsia 11 0 4 0 Dry Mouth 9 0 3 0 Skin and Cutaneous Disorders Rash3 53 5 12 0 Dermatitis Acneiform/Acne 35 1 7 0 Dry Skin 15 0 5 0 Photosensitivity Reaction 13 2 0 0 Pruritus 11 1 4 0 Nail abnormalities4 9 0 0 0 Alopecia 8 N/A 0 N/A Vascular Disorders Hypertension/Hypertensive Crisis/Accelerated Hypertension 33 9 5 1 Nervous System Disorders Headache 26 1 9 0 Dysgeusia 8 0 3 0 General Disorders Fatigue5 24 6 23 1 Infections Upper Respiratory Tract Infections6 23 0 16 0 Metabolic and Nutritional Disorders Decreased Appetite 21 4 12 0 Hypocalcemia 11 2 3 0 Investigations ECG QT Prolonged7 14 8 1 1 Eye Disorders Corneal Abnormalities7 13 0 1 0 Blurred Vision 9 0 1 0 Renal Disorders Proteinuria 10 0 2 0 Psychiatric Disorders Depression 10 2 3 0 Endocrine Disorders Hypothyroidism 6 0 0 0 Musculoskeletal Disorders Muscle Spasms 6 0 1 0 1CTCAE version 3 was used to grade adverse events.
2Includes abdominal pain, abdominal pain upper, lower abdominal pain and abdominal discomfort.
3Includes rash, rash (erythematous, generalized, macular, maculo-papular, papular, pruritic, and exfoliative), dermatitis, dermatitis bullous, generalized erythema, and eczema.
4Includes nail disorder, nail bed inflammation, nail bed tenderness, paronychia, nail bed infection, and nail infection.
5Included in Table 1 due to the increased incidence of severe fatigue in the CAPRELSA group compared to the placebo group.
6Includes laryngitis, nasopharyngitis, pharyngitis, sinusitis, upper respiratory tract infection, acute sinusitis, rhinitis, and tracheitis.
769% had QT prolongation > 450ms and 7% had QT prolongation > 500ms by ECG using Fridericia correction.
8Includes corneal edema, corneal opacity, corneal dystrophy, corneal pigmentation, keratopathy, arcus lipoides, corneal deposits, acquired corneal dystrophy. Clinically important uncommon adverse drug reactions in patients who received CAPRELSA versus patients who received placebo included pancreatitis (0.4% vs. 0%) and heart failure (0.9% vs. 0%). Blurred vision was more common in patients who received CAPRELSA versus patients who received placebo for medullary thyroid cancer (9% vs. 1%, respectively). Scheduled slit lamp examinations revealed corneal opacities (vortex keratopathies) in treated patients, which can lead to halos and decreased visual acuity. Perform ophthalmologic examination, including slit lamp examination, in patients who report visual changes. Class effects CAPRELSA is an inhibitor of vascular endothelial growth factor receptor (VEGFR) signaling. Inhibition of VEGFR signaling can result in intestinal perforation. Intestinal perforation occurred in 0.4% of CAPRELSA treated patients versus 0% of placebo treated patients. The incidence of Grade 1-2 bleeding events was 14% in patients receiving CAPRELSA compared with 7% on placebo in the randomized portion of the medullary thyroid cancer (MTC) study.2 Table 2 : Per-Patient Incidence of Selected Laboratory Abnormalities in Patients with MTC Occurring at a Higher Incidence in CAPRELSA-Treated Patients [Between-Arm Difference of ≥ 5% (All Grades)1]
Laboratory Abnormalities CAPRELSA 300 mg
N=231 Placebo
N=99 All Grades (%) Grade 3–4 (%) All Grades (%) Grade 3–4 (%) Chemistries Hypocalcemia 57 6 25 3 ALT Increased 51 2 19 0 Hypoglycemia 24 0 7 1 Creatinine Increased 16 0 1 0 Hypomagnesemia 7 < 1 2 0 Hematologic Neutropenia 10 < 1 5 2 Thrombocytopenia 9 0 3 0 1CTCAE version 3 was used to grade laboratory abnormalities. No patient with a Grade 3-4 ALT elevation had a concomitant increase in bilirubin in the MTC study. Read the Caprelsa (vandetanib) Side Effects Center for a complete guide to possible side effectsLearn More »
- QT Prolongation and Torsades de Pointes [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
- Skin Reactions and Stevens-Johnson Syndrome [see WARNINGS AND PRECAUTIONS]
- Interstitial Lung Disease [see WARNINGS AND PRECAUTIONS]
- Ischemic Cerebrovascular Events [see WARNINGS AND PRECAUTIONS]
- Hemorrhage [see WARNINGS AND PRECAUTIONS]
- Heart Failure [see WARNINGS AND PRECAUTIONS]
- Diarrhea [see WARNINGS AND PRECAUTIONS]
- Hypothyroidism [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Reversible Posterior Leukoencephalopathy Syndrome [see WARNINGS AND PRECAUTIONS]
- Embryofetal Toxicity [see WARNINGS AND PRECAUTIONS]
System Organ Class Preferred Term CAPRELSA 300 mg
N=231 Placebo
N=99 All Grades (%) Grade 3-4 (%) All Grades (%) Grade 3-4 (%) Gastrointestinal Disorders Diarrhea/Colitis 57 11 27 2 Nausea 33 1 16 0 Abdominal Pain2 21 3 11 0 Vomiting 15 1 7 0 Dyspepsia 11 0 4 0 Dry Mouth 9 0 3 0 Skin and Cutaneous Disorders Rash3 53 5 12 0 Dermatitis Acneiform/Acne 35 1 7 0 Dry Skin 15 0 5 0 Photosensitivity Reaction 13 2 0 0 Pruritus 11 1 4 0 Nail abnormalities4 9 0 0 0 Alopecia 8 N/A 0 N/A Vascular Disorders Hypertension/Hypertensive Crisis/Accelerated Hypertension 33 9 5 1 Nervous System Disorders Headache 26 1 9 0 Dysgeusia 8 0 3 0 General Disorders Fatigue5 24 6 23 1 Infections Upper Respiratory Tract Infections6 23 0 16 0 Metabolic and Nutritional Disorders Decreased Appetite 21 4 12 0 Hypocalcemia 11 2 3 0 Investigations ECG QT Prolonged7 14 8 1 1 Eye Disorders Corneal Abnormalities7 13 0 1 0 Blurred Vision 9 0 1 0 Renal Disorders Proteinuria 10 0 2 0 Psychiatric Disorders Depression 10 2 3 0 Endocrine Disorders Hypothyroidism 6 0 0 0 Musculoskeletal Disorders Muscle Spasms 6 0 1 0 1CTCAE version 3 was used to grade adverse events.
2Includes abdominal pain, abdominal pain upper, lower abdominal pain and abdominal discomfort.
3Includes rash, rash (erythematous, generalized, macular, maculo-papular, papular, pruritic, and exfoliative), dermatitis, dermatitis bullous, generalized erythema, and eczema.
4Includes nail disorder, nail bed inflammation, nail bed tenderness, paronychia, nail bed infection, and nail infection.
5Included in Table 1 due to the increased incidence of severe fatigue in the CAPRELSA group compared to the placebo group.
6Includes laryngitis, nasopharyngitis, pharyngitis, sinusitis, upper respiratory tract infection, acute sinusitis, rhinitis, and tracheitis.
769% had QT prolongation > 450ms and 7% had QT prolongation > 500ms by ECG using Fridericia correction.
8Includes corneal edema, corneal opacity, corneal dystrophy, corneal pigmentation, keratopathy, arcus lipoides, corneal deposits, acquired corneal dystrophy. Clinically important uncommon adverse drug reactions in patients who received CAPRELSA versus patients who received placebo included pancreatitis (0.4% vs. 0%) and heart failure (0.9% vs. 0%). Blurred vision was more common in patients who received CAPRELSA versus patients who received placebo for medullary thyroid cancer (9% vs. 1%, respectively). Scheduled slit lamp examinations revealed corneal opacities (vortex keratopathies) in treated patients, which can lead to halos and decreased visual acuity. Perform ophthalmologic examination, including slit lamp examination, in patients who report visual changes. Class effects CAPRELSA is an inhibitor of vascular endothelial growth factor receptor (VEGFR) signaling. Inhibition of VEGFR signaling can result in intestinal perforation. Intestinal perforation occurred in 0.4% of CAPRELSA treated patients versus 0% of placebo treated patients. The incidence of Grade 1-2 bleeding events was 14% in patients receiving CAPRELSA compared with 7% on placebo in the randomized portion of the medullary thyroid cancer (MTC) study.2 Table 2 : Per-Patient Incidence of Selected Laboratory Abnormalities in Patients with MTC Occurring at a Higher Incidence in CAPRELSA-Treated Patients [Between-Arm Difference of ≥ 5% (All Grades)1]
Laboratory Abnormalities CAPRELSA 300 mg
N=231 Placebo
N=99 All Grades (%) Grade 3–4 (%) All Grades (%) Grade 3–4 (%) Chemistries Hypocalcemia 57 6 25 3 ALT Increased 51 2 19 0 Hypoglycemia 24 0 7 1 Creatinine Increased 16 0 1 0 Hypomagnesemia 7 < 1 2 0 Hematologic Neutropenia 10 < 1 5 2 Thrombocytopenia 9 0 3 0 1CTCAE version 3 was used to grade laboratory abnormalities. No patient with a Grade 3-4 ALT elevation had a concomitant increase in bilirubin in the MTC study. Read the Caprelsa (vandetanib) Side Effects Center for a complete guide to possible side effectsLearn More »
Source: http://www.rxlist.com
The recommended dose of CAPRELSA is 300 mg taken orally once daily until disease progression or unacceptable toxicity occurs. CAPRELSA may be taken with or without food. Do not take a missed dose within 12 hours of the next dose. Do not crush CAPRELSA tablets. The tablets can be dispersed in 2 ounces of water by stirring for approximately 10 minutes (will not completely dissolve). Do not use other liquids for dispersion. Swallow immediately after dispersion. Mix any remaining residue with 4 additional ounces of water and swallow. The dispersion can also be administered through nasogastric or gastrostomy tubes. Dosage Adjustment For adverse reactions The 300 mg daily dose can be reduced to 200 mg (two 100 mg tablets) and then to 100 mg for Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or greater toxicities. Interrupt CAPRELSA for the following:
- Corrected QT interval, Fridericia (QTcF) greater than 500 ms: Resume at a reduced dose when the QTcF returns to less than 450 ms.
- CTCAE Grade 3 or greater toxicity: Resume at a reduced dose when the toxicity resolves or improves to CTCAE Grade 1.
Source: http://www.rxlist.com
Effect Of CYP3A4 Inducers On CAPRELSA Rifampicin, a strong CYP3A4 inducer, decreased vandetanib plasma concentrations. Avoid concomitant use of known strong CYP3A4 inducers during CAPRELSA therapy. Avoid concomitant use of St. John's Wort because it can decrease vandetanib exposure unpredictably [see CLINICAL PHARMACOLOGY]. Effect Of CAPRELSA On OCT2 Transporter CAPRELSA increased plasma concentrations of metforman that is transported by the organic cation transporter type 2 (OCT2). Use caution and closely monitor for toxicities when administering CAPRELSA with drugs that are transported by OCT2 [see CLINICAL PHARMACOLOGY]. Effect Of CAPRELSA On Digoxin CAPRELSA increased plasma concentrations of digoxin. Use caution and closely monitor for toxicities when administering CAPRELSA with digoxin [see CLINICAL PHARMACOLOGY]. Drugs That Prolong The QT Interval Avoid concomitant use of CAPRELSA with agents that may prolong the QT interval [see WARNINGS AND PRECAUTIONS]. Read the Caprelsa Drug Interactions Center for a complete guide to possible interactions Learn More »
Source: http://www.rxlist.com
CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA.
Source: http://www.rxlist.com
Do not use in patients with congenital long QT syndrome [see BOXED WARNING]. Last reviewed on RxList: 4/10/2014
This monograph has been modified to include the generic and brand name in many instances.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
In the event of an overdose, monitor patients closely for QTc prolongation. Because of the 19-day half-life, adverse reactions may not resolve quickly.
Source: http://www.rxlist.com
Dosage Forms & Strengths CAPRELSA 100-mg tablets are white, round, biconvex, film-coated, and intagliated with 'Z 100' on one side and plain on the reverse side.
CAPRELSA 300-mg tablets are white, oval, biconvex, film-coated, and intagliated with 'Z 300' on one side and plain on the reverse side. 100 mg Tablets Available in bottles containing 30 tablets (NDC 0310–7820–30).
300 mg Tablets Available in bottles containing 30 tablets (NDC 0310–7840–30). Storage And Handling CAPRELSA tablets should be stored at 25°C (77°F); excursions permitted to 15°C – 30°C (59°F – 86°F) [See USP controlled room temperature]. Procedures for proper handling and disposal of anticancer drugs should be considered. A guideline on this subject has been published.1 Do not crush CAPRELSA tablets. REFERENCES “OSHA Hazardous Drugs” (OSHA Technical Manual). OSHA. Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Issued 03/2014 Last reviewed on RxList: 4/10/2014
This monograph has been modified to include the generic and brand name in many instances.
CAPRELSA 300-mg tablets are white, oval, biconvex, film-coated, and intagliated with 'Z 300' on one side and plain on the reverse side. 100 mg Tablets Available in bottles containing 30 tablets (NDC 0310–7820–30).
300 mg Tablets Available in bottles containing 30 tablets (NDC 0310–7840–30). Storage And Handling CAPRELSA tablets should be stored at 25°C (77°F); excursions permitted to 15°C – 30°C (59°F – 86°F) [See USP controlled room temperature]. Procedures for proper handling and disposal of anticancer drugs should be considered. A guideline on this subject has been published.1 Do not crush CAPRELSA tablets. REFERENCES “OSHA Hazardous Drugs” (OSHA Technical Manual). OSHA. Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Issued 03/2014 Last reviewed on RxList: 4/10/2014
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
QT Prolongation And Torsades De Pointes CAPRELSA can prolong the QT interval in a concentration-dependent manner [see CLINICAL PHARMACOLOGY]. Torsades de pointes, ventricular tachycardia and sudden deaths have occurred in patients treated with CAPRELSA. Do not start CAPRELSA treatment in patients whose QTcF interval is greater than 450 ms. Do not administer CAPRELSA to patients who have a history of Torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure. CAPRELSA has not been studied in patients with ventricular arrhythmias or recent myocardial infarction. Vandetanib exposure is increased in patients with impaired renal function. Reduce the starting dose to 200 mg in patients with moderate to severe renal impairment and monitor QT interval frequently. Obtain an ECG and serum potassium, calcium, magnesium and TSH at baseline, 2-4 weeks and 8-12 weeks after starting treatment with CAPRELSA, and every 3 months thereafter. Monitor electrolytes and ECGs more frequently in patients who experience diarrhea. Following any dose reduction for QT prolongation or any dose interruption greater than 2 weeks, conduct QT assessments as described above. Maintain serum potassium levels of 4 mEq/L or higher (within normal range) and maintain serum magnesium and calcium levels within normal ranges to reduce the risk of QT prolongation. Avoid using CAPRELSA with drugs known to prolong the QT interval [see DRUG INTERACTIONS]. If such drugs are given to patients already receiving CAPRELSA and no alternative therapy exists, perform ECG monitoring of the QT interval more frequently. Stop CAPRELSA in patients who develop a QTcF greater than 500 ms until the QTcF returns to less than 450 ms. Dosing of CAPRELSA can then be resumed at a reduced dose [see DOSAGE AND ADMINISTRATION]. Skin Reactions And Stevens-Johnson Syndrome Severe skin reactions (including Stevens-Johnson syndrome), some leading to death, have occurred in patients treated with CAPRELSA. Consider permanent discontinuation of CAPRELSA for severe skin reactions [see DOSAGE AND ADMINISTRATION]. Photosensitivity reactions can occur during CAPRELSA treatment and up to 4 months after treatment discontinuation. Interstitial Lung Disease Interstitial Lung Disease (ILD) or pneumonitis, including fatalities, has occurred in patients treated with CAPRELSA. Consider a diagnosis of ILD in patients presenting with non-specific respiratory signs and symptoms. Interrupt CAPRELSA for acute or worsening pulmonary symptoms. Discontinue CAPRELSA if ILD is confirmed. Ischemic Cerebrovascular Events Ischemic cerebrovascular events, including fatalities, occurred in patients treated with CAPRELSA. In the randomized medullary thyroid cancer (MTC) study, ischemic cerebrovascular events occurred more frequently with CAPRELSA compared to placebo (1.3% compared to 0%). The safety of resumption of CAPRELSA therapy after resolution of an ischemic cerebrovascular event has not been studied. Discontinue CAPRELSA in patients who experience a severe ischemic cerebrovascular event. Hemorrhage Serious hemorrhagic events, including fatalities, occurred in patients treated with CAPRELSA. Do not administer CAPRELSA to patients with a recent history of hemoptysis of ≥ ½ teaspoon of red blood. Discontinue CAPRELSA in patients with severe hemorrhage. Heart Failure Heart failure, including fatalities, occurred in patients treated with CAPRELSA. Monitor for signs and symptoms of heart failure. Consider discontinuation of CAPRELSA in patients with heart failure. Heart failure may not be reversible upon stopping CAPRELSA. Diarrhea Diarrhea of Grade 3 or greater severity occurred in 11% of patients receiving CAPRELSA in the randomized MTC study. If diarrhea occurs, carefully monitor serum electrolytes and ECGs to reduce the risk and enable early detection of QT prolongation resulting from dehydration. Interrupt CAPRELSA for severe diarrhea. Upon improvement, resume CAPRELSA at a reduced dose [see DOSAGE AND ADMINISTRATION]. Hypothyroidism In the randomized MTC study in which 90% of the patients enrolled had prior thyroidectomy, increased dosing of thyroid replacement therapy was required in 49% of CAPRELSA-treated patients compared to 17% of placebo-treated patients. Obtain Thyroid-stimulating hormone (TSH) at baseline, at 2 -4 weeks and 8 -12 weeks after starting treatment with CAPRELSA, and every 3 months thereafter. If signs or symptoms of hypothyroidism occur, examine thyroid hormone levels and adjust thyroid replacement therapy accordingly. Hypertension Hypertension, including hypertensive crisis, has occurred in patients treated with CAPRELSA. Monitor all patients for hypertension. Dose reduction or interruption for hypertension may be necessary. If hypertension cannot be controlled, do not resume CAPRELSA [see DOSAGE AND ADMINISTRATION]. Reversible Posterior Leukoencephalopathy Syndrome Reversible posterior leukoencephalopathy syndrome (RPLS), a syndrome of subcortical vasogenic edema diagnosed by an MRI of the brain, has occurred in patients treated with CAPRELSA. Consider this syndrome in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function. In clinical studies, three of four patients who developed RPLS while taking CAPRELSA also had hypertension. Discontinue CAPRELSA treatment in patients with RPLS. Drug Interactions Avoid administration of CAPRELSA with anti-arrhythmic drugs (including but not limited to amiodarone, disopyramide, procainamide, sotalol, dofetilide) and other drugs that may prolong the QT interval (including but not limited to chloroquine, clarithromycin, dolasetron, granisetron, haloperidol, methadone, moxifloxacin, and pimozide) [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY]. Renal Impairment Vandetanib exposure is increased in patients with impaired renal function. Reduce the starting dose to 200 mg in patients with moderate to severe renal impairment and monitor the QT interval closely. There is no information available for patients with end-stage renal disease requiring dialysis [see BOXED WARNING, DOSAGE AND ADMINISTRATION, Use in Specific Populations and CLINICAL PHARMACOLOGY]. Hepatic Impairment CAPRELSA is not recommended for use in patients with moderate and severe hepatic impairment, as safety and efficacy have not been established [see DOSAGE AND ADMINISTRATION]. Embryofetal Toxicity Based on its mechanism of action, CAPRELSA can cause fetal harm when administered to a pregnant woman. In nonclinical studies in rats, vandetanib was embryotoxic, fetotoxic, and teratogenic at exposures equivalent to or lower than those expected at the recommended human dose of 300 mg/day and had adverse effects on female fertility, embryofetal development, and postnatal development of pups. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Women of childbearing potential should avoid pregnancy. Advise women of childbearing potential that they must use effective contraception during CAPRELSA treatment and for at least four months following the last dose of CAPRELSA [see Use In Specific Populations]. CAPRELSA REMS (Risk Evaluation And Mitigation Strategy) Program Because of the risk of QT prolongation, Torsades de pointes, and sudden death, CAPRELSA is available only through a restricted distribution program called the CAPRELSA REMS Program. Only prescribers and pharmacies certified with the program are able to prescribe and dispense CAPRELSA. To learn about the specific REMS requirements and to enroll in the CAPRELSA REMS Program, call 1-800-236-9933 or visit www.caprelsarems.com. Patient Counseling Information See FDA-approved patient labeling (medication guide)
This monograph has been modified to include the generic and brand name in many instances.
- QT Prolongation and Torsades de Pointes: Advise patients to contact their healthcare provider in the event of syncope, pre-syncopal symptoms, and cardiac palpitations. Advise patients that their healthcare provider will monitor their electrolytes and ECGs during treatment [see WARNINGS AND PRECAUTIONS].
- Severe skin reactions and Stevens-Johnson Syndrome: Advise patients to contact their healthcare provider in the event of skin reactions or rash. [see WARNINGS AND PRECAUTIONS].
- Interstitial Lung Disease (ILD): Advise patients to contact their health care provider in the event of sudden onset or worsening of breathlessness, persistent cough or fever. [see WARNINGS AND PRECAUTIONS].
- Diarrhea: Advise patients to contact their healthcare provider in the event of diarrhea [see WARNINGS AND PRECAUTIONS ]
- Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Advise patients to contact their healthcare provider in the event of seizures, headaches, visual disturbances, confusion or difficulty thinking [see WARNINGS AND PRECAUTIONS]
- Fetal Toxicity: Because CAPRELSA can cause fetal harm, advise patients of reproductive potential to use effective contraception during therapy and for at least four months following their last dose of CAPRELSA, and to immediately contact their health care provider if pregnancy is suspected or confirmed [see Pregnancy, Females and Males of Reproductive Potential].
- Nursing Infants: Because of the potential for serious adverse reactions in nursing infants from CAPRELSA, advise breast feeding mothers to discontinue nursing while receiving therapy [see Nursing Mothers].
- Photosensitivity: Advise patients to use appropriate sun protection due to the increased susceptibility to sunburn while taking CAPRELSA and for at least 4 months after drug discontinuation [see WARNINGS AND PRECAUTIONS].
- Administration: Advise patients that CAPRELSA can be taken with or without food and not to crush CAPRELSA tablets [see Pharmacokinetics].
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
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