without end [30:ULN to 3 times ULN): No abemaciclib dosage adjustment necessary. Grade 2 (ALT, AST >3 to 5 times ULN) without increase in total bilirubin >2 times ULN: No abemaciclib dosage adjustment necessary. Persistent or recurrent grade 2 or grade 3 (ALT, AST >5 to 20 times ULN) without increase in total bilirubin >2 times ULN: Withhold abemaciclib until toxicity resolves to baseline or grade 1, then resume at the next lower dose. AST and/or ALT >3 times ULN with total bilirubin >2 times ULN (in the absence of cholestasis): Discontinue abemaciclib treatment. Grade 4 (ALT, AST >20 times ULN): Discontinue abemaciclib treatment. Dosing: Adjustment for Toxicity Recommended abemaciclib dosage adjustments for adverse reactions: Starting dose 200 mg twice a day (monotherapy): First dose reduction: Reduce abemaciclib dose to 150 mg twice daily. Second dose reduction: Reduce abemaciclib dose to 100 mg twice daily. Third dose reduction: Reduce abemaciclib dose to 50 mg twice daily. Starting dose 150 mg twice a day (in combination with fulvestrant): First dose reduction: Reduce abemaciclib dose to 100 mg twice daily. Second dose reduction: Reduce abemaciclib dose to 50 mg twice daily. If unable to tolerate 50 mg twice daily: Discontinue abemaciclib treatment. Hematologic toxicities: Note: If blood cell growth factors are required, withhold abemaciclib dose for at least 48 hours after the last dose of the growth factor and until toxicity resolves to grade 2 or lower; resume abemaciclib at the next lower dose (unless already reduced due to the toxicity that required the growth factor). Grade 1 or 2: No abemaciclib dosage adjustment necessary. Grade 3: Withhold abemaciclib until toxicity resolves to grade 2 or lower (no abemaciclib dosage reduction is necessary). Grade 4 or recurrent grade 3: Withhold abemaciclib until toxicity resolves to grade 2 or lower and then resume abemaciclib at the next lower dose. Non-hematologic toxicities: Diarrhea: At the first sign of loose stools, begin management with antidiarrheal agents and increase oral fluid intake. Grade 1: No abemaciclib dosage adjustment necessary. Grade 2: If toxicity does not resolve to grade 1 or lower within 24 hours, withhold abemaciclib until resolution (no abemaciclib dosage reduction is necessary). Grade 2 that persists or recurs after resumption at the same dose (despite maximal supportive measures): Withhold abemaciclib until toxicity resolves to grade 1 or lower and then resume abemaciclib at the next lower dose. Grade 3 or 4 or requires hospitalization: Withhold abemaciclib until toxicity resolves to grade 1 or lower and then resume abemaciclib at the next lower dose. Other toxicities (excluding diarrhea, hematologic toxicity or hepatotoxicity): Grade 1 or 2: No abemaciclib dosage adjustment necessary. Persistent or recurrent grade 2 toxicity that does not resolve to baseline or grade 1 within 7 days (despite maximal supportive measures): Withhold abemaciclib until toxicity resolves to baseline or to grade 1 or lower and then resume abemaciclib at the next lower dose. Grade 3 or 4: Withhold abemaciclib until toxicity resolves to baseline or to grade 1 or lower and then resume abemaciclib at the next lower dose. Administration Administer at approximately the same times each day. May be administered with or without food. Swallow whole, do not crush, chew, or split tablets (do not ingest if tablets are broken, cracked, or not fully intact). Dietary Considerations Avoid grapefruit and grapefruit products. A high-fat, high-calorie meal (800 to 1,000 calories with 500 to 600 calories from fat) increases exposure. Storage Store at 20 C to 25 C (68 F to 77 F); excursions are permitted between 15 C and 30 C (59 F and 86 F). Drug Interactions Aprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination 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 CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination 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 Abemaciclib. Avoid combination CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Abemaciclib. Monitor therapy CYP3A4 Inhibitors (Strong): May increase the serum concentration of Abemaciclib. Management: In patients taking abemaciclib at a dose of 200 mg or 150 mg twice daily, reduce the dose to 100 mg twice daily when combined with strong CYP3A4 inhibitors. In patients taking abemaciclib 100 mg twice daily, decrease the dose to 50 mg twice daily. 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 Dasatinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy 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. Avoid combination Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification Fosaprepitant: 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 Grapefruit Juice: May increase the serum concentration of Abemaciclib. Avoid combination Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination Ketoconazole (Systemic): May increase the serum concentration of Abemaciclib. Avoid combination Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification MetFORMIN: Abemaciclib may increase the serum concentration of MetFORMIN. 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 Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination Netupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. Consider therapy modification Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. 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 Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy St John's Wort: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification 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 Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Avoid combination Adverse Reactions >10%: Central nervous system: Fatigue (65%), headache (20%), dizziness (11%) Dermatologic: Alopecia (12%) Endocrine & metabolic: Weight loss (14%) Gastrointestinal: Diarrhea (90%), nausea (64%), decreased appetite (45%), abdominal pain (39%), vomiting (35%), constipation (17%), stomatitis (14%), xerostomia (14%), dysgeusia (12%) Hematologic & oncologic: Anemia (25% to 68%; grade 3: 5%), decreased absolute lymphocyte count (42%; grade 3: 13%; grade 4:]} Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... Ozempic Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the... Ogivri Ogivri (trastuzumab-dkst) is a HER2 / neu receptor antagonist biosimilar to Herceptin indicated for... Sublocade Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the... More} } continual
you're taking Abemaciclib merchant
EmoticonEmoticon