Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Rydapt: 25 mg [contains cremophor rh40]
Pharmacology
Mechanism of Action
Midostaurin is a tyrosine kinase inhibitor which inhibits multiple receptors, such as wild type FLT3, FLT3 mutant kinases ITD and TKD, KIT (wild type and D816V mutant), PDGFRα/β, VEGFR2, and members of the serine/threonine protein kinase C (PKC) family.
Midostaurin inhibits FLT3 receptor signaling and cell proliferation, and induces apoptosis in ITD- and TKD- mutant expressing leukemic cells, as well as in cells overexpressing wild type FLT3 and PDGFR. It also may inhibit KIT signaling, cell proliferation, and histamine release (and induces apoptosis) in mast cells.
Pharmacokinetics/Pharmacodynamics
Absorption
Exposure was increased 1.2- or 1.6-fold when administered with a standard or high-fat meal, respectively, compared to the fasted state. Midostaurin Cmax was reduced 20% and 27%, respectively, when administered with a standard or high-fat meal compared to a fasted state.
Distribution
95.2 L
Metabolism
Primarily hepatic via CYP3A4 to active metabolites CGP62221 and CGP52421
Excretion
Feces (95%; 91% as metabolites and 4% as unchanged drug); urine (5%)
Time to Peak
1 to 3 hours (fasted state); 2.5 to 3 hours (with standard or high-fat meal)
Half-Life Elimination
19 hours (midostaurin); 32 hours (CGP62221); 482 hours (CGP52421)
Protein Binding
>99.8% bound to plasma proteins (parent drug, CGP62221, and CGP52421); midostaurin is mainly bound to α1-acid glycoprotein
Use: Labeled Indications
Acute myeloid leukemia, FLT3-positive: Treatment of adult patients with newly diagnosed FLT3 mutation-positive (as detected by an approved test) acute myeloid leukemia (AML), in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy
Limitations of use: Not indicated as single-agent induction therapy for the treatment of patients with AML.
Mast cell leukemia: Treatment of adult patients with mast cell leukemia (MCL)
Systemic mastocytosis: Treatment of adult patients with aggressive systemic mastocytosis (ASM) or systemic mastocytosis with associated hematological neoplasm (SM-AHN)
Contraindications
Hypersensitivity to midostaurin or any component of the formulation
Dosage and Administration
Dosing: Adult
Note: Midostaurin is associated with a moderate emetic potential; administer antiemetics prior to treatment to prevent nausea and vomiting.
Acute myeloid leukemia (AML), FLT3-positive: Oral:
Induction: 50 mg twice daily on days 8 to 21 of each induction cycle (in combination with daunorubicin and cytarabine); administer a second induction cycle if there is definitive evidence of (clinically significant) residual leukemia (Stone 2017)
Consolidation: 50 mg twice daily on days 8 to 21 of each 28-day consolidation cycle (in combination with high-dose cytarabine) for 4 consolidation cycles (Stone 2017)
Maintenance (off-label): 50 mg twice daily on days 1 to 28 of each 28-day maintenance cycle for 12 cycles or until relapse, whichever occurs first (Stone 2017).
Mast cell leukemia: Oral: 100 mg twice daily until disease progression or unacceptable toxicity (Gotlib 2016)
Systemic mastocytosis (aggressive systemic mastocytosis or systemic mastocytosis with associated hematological neoplasm): Oral: 100 mg twice daily until disease progression or unacceptable toxicity (Gotlib 2016)
Missed doses: If a dose is missed or vomited, do not make up the dose; take the next dose at the usually scheduled time.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Adjustment for Toxicity
Systemic mastocytosis (aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, or mast cell leukemia):
Hematologic toxicity (attributed to midostaurin):
ANC <1,000/mm3 (in patients without mast cell leukemia) or ANC <500/mm3 (in patients with baseline ANC of 500 to 1,500/mm3): Interrupt midostaurin; when ANC has improved to ≥1,000/mm3, resume therapy at a reduced dose of 50 mg twice daily and if tolerated, may increase dose to 100 mg twice daily.
Persistently low ANC for >21 days (associated with midostaurin): Discontinue midostaurin
Platelets <50,000/mm3 (in patients without mast cell leukemia) or platelets <25,000/mm3 (in patients with baseline platelet count of 25,000 to 75,000/mm3): Interrupt midostaurin; when platelets have improved to ≥50,000/mm3, resume therapy at a reduced dose of 50 mg twice daily and if tolerated, may increase dose to 100 mg twice daily.
Persistently low platelet count for >21 days (associated with midostaurin): Discontinue midostaurin
Hemoglobin <8 g/dL (in patients without mast cell leukemia) or life-threatening anemia in patients with baseline hemoglobin of 8 to 10 g/dL: Interrupt midostaurin; when hemoglobin has improved to ≥8 g/dL, resume therapy at a reduced dose of 50 mg twice daily and if tolerated, may increase dose to 100 mg twice daily.
Persistently low hemoglobin for >21 days (associated with midostaurin): Discontinue midostaurin
Nonhematologic toxicity:
Nausea/vomiting, grade 3 or 4 (despite optimal antiemetic prophylaxis): Interrupt midostaurin for 3 days (6 doses), then resume therapy at a reduced dose of 50 mg twice daily. If tolerated, increase dose to 100 mg twice daily.
Other grade 3 or 4 toxicities: Interrupt midostaurin until improvement to ≤ grade 2, then resume therapy at a reduced dose of 50 mg twice daily. If tolerated, increase dose to 100 mg twice daily.
All indications: Pulmonary toxicity: Signs/symptoms of interstitial lung disease or pneumonitis without infectious etiology): Discontinue midostaurin.
Administration
Midostaurin is associated with a moderate emetic potential; administer antiemetics prior to treatment to prevent nausea and vomiting.
Oral: Administer with food at approximately 12-hour intervals. Do not open or crush the capsules.
Storage
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in the original package to protect from moisture.
Drug Interactions
Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy
Aprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Monitor therapy
Chloroquine: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Chloroquine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Avoid combination
Clofazimine: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Clofazimine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy
Conivaptan: May increase the serum concentration of Midostaurin. Management: Seek alternatives to the concomitant use of midostaurin and conivaptan if possible. If concomitant use cannot be avoided, monitor patients for increased risk of adverse reactions. Consider therapy modification
CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy
CYP3A4 Inducers (Strong): May decrease the serum concentration of Midostaurin. Avoid combination
CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Midostaurin. Management: Seek alternatives to the concomitant use of midostaurin and strong CYP3A4 inhibitors if possible. If concomitant use cannot be avoided, monitor patients for increased risk of adverse reactions. Exceptions are discussed in separate monographs. Exceptions: Ceritinib; Clarithromycin; Saquinavir; Voriconazole. Consider therapy modification
Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification
Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Consider therapy modification
DilTIAZem: May increase the serum concentration of Midostaurin. Management: Seek alternatives to the concomitant use of midostaurin and diltiazem if possible. If concomitant use cannot be avoided, monitor patients for increased risk of adverse reactions. Consider therapy modification
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination
Domperidone: QT-prolonging Agents (Moderate Risk) may enhance the QTc-prolonging effect of Domperidone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Consider therapy modification
Duvelisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy
Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy
Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy
Fexinidazole [INT]: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Avoid combination
Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy
Fosnetupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination
Gadobenate Dimeglumine: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Gadobenate Dimeglumine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy
Grapefruit Juice: May increase the serum concentration of Midostaurin. Management: Seek alternatives to the concomitant use of midostaurin and grapefruit juice if possible. If concomitant use cannot be avoided, monitor patients for increased risk of adverse reactions Consider therapy modification
Halofantrine: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Halofantrine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy
Haloperidol: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Haloperidol. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy
Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination
Larotrectinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy
Lefamulin: May enhance the QTc-prolonging effect of QT-prolonging CYP3A4 Substrates. Management: Do not use lefamulin tablets with QT-prolonging CYP3A4 substrates. Lefamulin prescribing information lists this combination as contraindicated. Avoid combination
Lofexidine: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Lofexidine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy
Lorlatinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences. Consider therapy modification
Mesalamine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy
MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification
Netupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy
Ondansetron: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Ondansetron. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy
Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy
Pentamidine (Systemic): QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Pentamidine (Systemic). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy
Pimozide: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Avoid combination
Posaconazole: May increase the serum concentration of QT-prolonging CYP3A4 Substrates. Such increases may lead to a greater risk for proarrhythmic effects and other similar toxicities. Avoid combination
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy
QT-prolonging Agents (Highest Risk): May enhance the QTc-prolonging effect of Midostaurin. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Consider therapy modification
QT-prolonging Antidepressants (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Miscellaneous Agents (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy
QT-prolonging Antipsychotics (Moderate Risk): QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of QT-prolonging Antipsychotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Exceptions: Pimozide. Monitor therapy
QT-prolonging Class IC Antiarrhythmics (Moderate Risk): QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of QT-prolonging Class IC Antiarrhythmics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy
QT-prolonging Kinase Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Miscellaneous Agents (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy
QT-prolonging Miscellaneous Agents (Moderate Risk): May enhance the QTc-prolonging effect of Midostaurin. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Exceptions: Chloroquine; Clofazimine; Domperidone; Gadobenate Dimeglumine; Halofantrine; Lofexidine. Monitor therapy
QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Miscellaneous Agents (Moderate Risk). QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk) may increase the serum concentration of QT-prolonging Miscellaneous Agents (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy
QT-prolonging Quinolone Antibiotics (Moderate Risk): QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of QT-prolonging Quinolone Antibiotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy
QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of Midostaurin. QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk) may increase the serum concentration of Midostaurin. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Consider therapy modification
Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy
Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy
Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy
St John's Wort: May decrease the serum concentration of Midostaurin. Avoid combination
Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification
Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy
Adverse Reactions
>10%:
Cardiovascular: Edema (40%), prolonged Q-T interval on ECG (11%)
Central nervous system: Headache (26% to 46%), fatigue (34%), dizziness (13%), insomnia (11% to 12%)
Dermatologic: Hyperhidrosis (14%), skin rash (14%)
Endocrine & metabolic: Hyperglycemia (20% to 80%), hypocalcemia (39% to 74%), hyperuricemia (8% to 37%), increased gamma-glutamyl transferase (35%), hyponatremia (34%), hypoalbuminemia (27%), hypokalemia (25%), hyperkalemia (23%), hypophosphatemia (22%), hypernatremia (21%), hypomagnesemia (20%)
Gastrointestinal: Nausea (47% to 83%), vomiting (19% to 68%), mucositis (66%), diarrhea (54%), increased serum lipase (37%), abdominal pain (34%), constipation (29%), increased serum amylase (20%), hemorrhoids (15%), gastrointestinal hemorrhage (14%)
Genitourinary: Urinary tract infection (16%)
Hematologic & oncologic: Febrile neutropenia (8% to 83%; grades ≥3: 84%), lymphocytopenia (66%; grades ≥3: 42%), leukopenia (61%; grades ≥3: 19%), anemia (60%; grades ≥3: 38%), thrombocytopenia (50%; grades ≥3: 27%), neutropenia (49%; grades ≥3: 22%), petechia (36%), prolonged partial thromboplastin time (13%; grades ≥3: 3%)
Hepatic: Increased serum ALT (31 % to 71%), increased serum alkaline phosphatase (39%), increased serum AST (32%), hyperbilirubinemia (29%)
Infection: Localized infection (24%; device related)
Neuromuscular & skeletal: Musculoskeletal pain (33% to 35%), arthralgia (14% to 19%)
Renal: Increased serum creatinine (25%), renal insufficiency (11% to 12%)
Respiratory: Upper respiratory tract infection (20% to 30%), epistaxis (12% to 28%), dyspnea (23%), cough (18%), pleural effusion (6% to 13%)
Miscellaneous: Fever (27%)
1% to 10%:
Cardiovascular: Hypotension (9%), hypertension (8%), cardiac failure (6%), thrombosis (5%), pericardial effusion (4%), ischemia (≤4%), myocardial infarction (≤4%)
Central nervous system: Disturbance in attention (7%), chills (5%), vertigo (5%), mental status changes (4%)
Dermatologic: Xeroderma (7%), cellulitis (≤7%), erysipelas (≤5%)
Endocrine & metabolic: Weight gain (6% to 7%), hypercalcemia (3%)
Gastrointestinal: Dyspepsia (6%), gastritis (3%)
Hematologic & oncologic: Bruise (6%), hematoma (6%)
Hypersensitivity: Hypersensitivity (4%)
Infection: Herpes virus infection (10%), sepsis (9%), fungal infection (7%)
Neuromuscular & skeletal: Tremor (4% to 6%)
Ophthalmic: Eyelid edema (3%)
Respiratory: Pneumonia (10%), bronchitis (6%), oropharyngeal pain (4%), pulmonary edema (3%), interstitial pulmonary disease (≤2%), pneumonitis (≤2%)
Warnings/Precautions
Concerns related to adverse effects:
- Bone marrow suppression: Lymphopenia, leukopenia, neutropenia, thrombocytopenia and anemia have been commonly observed in patients with systemic mastocytosis. Although the incidence of hematologic toxicity in acute myeloid leukemia (AML) may be confounded by concomitant chemotherapy, febrile neutropenia was reported at a slightly higher incidence in patients with AML receiving chemotherapy plus midostaurin (compared to chemotherapy plus placebo). Monitor blood counts.
- GI toxicity: Midostaurin is associated with a moderate emetic potential; administer antiemetics prior to treatment to prevent nausea and vomiting. Nausea and vomiting commonly occur; premedicate with antiemetics prior to administration. Diarrhea, abdominal pain, and constipation also occur frequently. Mucositis has also been reported.
- Hypersensitivity: Hypersensitivity reactions, including anaphylactic shock, angioedema, dyspnea, chest pain and flushing have been observed.
- QT prolongation: QT prolongation has been observed; consider ECG for QT interval assessment in patients on concurrent medications that may prolong the QT interval.
- Pulmonary toxicity: Interstitial lung disease and pneumonitis have been reported with midostaurin (either as monotherapy or in combination with other chemotherapy), some cases have been fatal. Monitor for pulmonary symptoms; discontinue in patients who develop signs/symptoms of interstitial lung disease or pneumonitis (without an infectious etiology).
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Other warnings/precautions:
- FLT3 mutation positivity: In the treatment of acute myeloid leukemia, midostaurin is approved for use only in patients who are FLT3 mutation-positive (as detected by an approved test).
Monitoring Parameters
FLT3 mutation status (in AML); CBC with differential (in patients with systemic mastocytosis: at least weekly for the first 4 weeks, every other week for the next 8 weeks, and monthly thereafter or as clinically indicated); pregnancy status within 7 days of therapy initiation in women of reproductive potential; signs/symptoms of pulmonary toxicity (interstitial lung disease and pneumonitis); consider ECG for QT interval assessment in patients on concurrent medications that may prolong the QT interval. Monitor adherence.
Pregnancy
Pregnancy Considerations
Based on the mechanism of action and data from animal reproduction studies, in utero exposure to midostaurin may cause fetal harm.
Pregnancy status should be verified within 7 days prior to therapy initiation. Females of reproductive potential and males with female partners of reproductive potential should use effective contraception during therapy and for at least 4 months after the last dose.
Females who may have been exposed to midostaurin during pregnancy (directly or through a male partner receiving midostaurin) should contact the Novartis Pharmaceuticals Corporation at 1-888-669-6682 and/or at https://psi.novartis.com.
Patient Education
What is this drug used for?
- It is used to treat a type of leukemia.
- It is used to treat mastocytosis.
Frequently reported side effects of this drug
- Mouth irritation
- Mouth sores
- Muscle pain
- Joint pain
- Bone pain
- Nosebleed
- Common cold symptoms
- Trouble sleeping
- Dry skin
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Blood clots like numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain; shortness of breath; fast heartbeat; or coughing up blood
- Infection
- Skin infection
- High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit
- Kidney problems like unable to pass urine, blood in the urine, change in amount of urine passed, or weight gain
- Electrolyte problems like mood changes, confusion, muscle pain or weakness, abnormal heartbeat, seizures, lack of appetite, or severe nausea or vomiting
- Bleeding like vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding
- Severe nausea
- Vomiting
- Severe diarrhea
- Severe constipation
- Flushing
- Chest pain
- Pinpoint red spots on skin
- Sweating a lot
- Shortness of breath
- Excessive weight gain
- Swelling of arms or legs
- Abnormal heartbeat
- Severe headache
- Severe dizziness
- Passing out
- Vision changes
- Trouble focusing
- Tremors
- Severe loss of strength and energy
- Severe pulmonary disorder like lung or breathing problems like difficulty breathing, shortness of breath, or a cough that is new or worse
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
