family [30:3 mg/dL: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Dosing: Adjustment for Toxicity Cardiotoxicity: Discontinue daunorubicin and cytarabine (liposomal) in patients with impaired cardiac function unless the benefits of continued treatment outweigh the toxicity risks. Hematologic toxicity: Do not initiate a new cycle until ANC recovers to >500/mm 3 and platelets recover to >50,000/mm 3 . Hematologic toxicity may require platelet transfusion support. Hypersensitivity reactions: Mild symptoms: Interrupt infusion immediately and manage symptoms as clinically appropriate. Upon symptom resolution, reinitiate infusion at 50% of the previous infusion rate; consider premedication with antihistamines and/or corticosteroids with subsequent daunorubicin and cytarabine (liposomal) doses. Moderate symptoms: Interrupt infusion immediately and manage symptoms as clinically appropriate. Do not reinitiate infusion. Premedicate with antihistamines and/or corticosteroids with subsequent daunorubicin and cytarabine (liposomal) doses prior to initiating infusion at the same rate. Severe or life-threatening symptoms: Interrupt infusion immediately and manage symptoms as clinically appropriate; monitor until symptom resolution. Permanently discontinue daunorubicin and cytarabine (liposomal). Reconstitution Allow vials to come to room temperature for 30 minutes prior to reconstitution. Reconstitute each vial with 19 mL sterile water for injection (using a sterile syringe) to a concentration of 2.2 mg/mL; swirl the vial contents for 5 minutes (using a timer) while gently inverting the vial every 30 seconds. Do not heat, vortex, or shake the vials vigorously. Allow reconstituted vials to rest for 15 minutes (product should be opaque, purple, with homogenous dispersion and essentially free of visible particulates). Gently invert each vial 5 times prior to withdrawing dose for further dilution. Transfer appropriate dose volume (dose is calculated based on the daunorubicin component) to an infusion bag containing 500 mL of NS or D5W (discard unused residual solution in the vial). Mix bag by gentle inversion; the final solution will be deep purple, translucent, with homogeneous dispersion and free from visible particulates. Administration Administer prophylactic antiemetics prior to infusion. For IV administration only; do not administer IM or SubQ. Administer over 90 minutes (for induction and consolidation cycles) via an infusion pump through a central venous or peripherally inserted central catheter. Do not use an in-line filter. Flush the line with NS or D5W after infusion. Do not mix with or administer with any other medications. If infusion-related reactions occur, premedication with antihistamines and/or corticosteroids may be necessary. The daunorubicin (liposomal) component may be an irritant; avoid extravasation. Storage Store intact vials 2 C to 8 C (36 F to 46 F) in an upright position. Protect from light (retain in original container). Reconstituted solution and solutions further diluted for infusion (if not used immediately) are stable for up to 4 hours when refrigerated. Drug Interactions Ado-Trastuzumab Emtansine: May enhance the cardiotoxic effect of Anthracyclines. Management: When possible, patients treated with ado-trastuzumab emtansine should avoid anthracycline-based therapy for up to 7 months after stopping ado-trastuzumab emtansine. Monitor closely for cardiac dysfunction in patients receiving this combination. Consider therapy modification 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 Bevacizumab: May enhance the cardiotoxic effect of Anthracyclines. Monitor therapy Cardiac Glycosides: May diminish the cardiotoxic effect of Anthracyclines. Anthracyclines may decrease the serum concentration of Cardiac Glycosides. The effects of liposomal formulations may be unique from those of the free drug, as liposomal formulation have unique drug disposition and toxicity profiles, and liposomes themselves may alter digoxin absorption/distribution. 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 Cyclophosphamide: May enhance the cardiotoxic effect of Anthracyclines. 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 Flucytosine: Cytarabine (Conventional) may diminish the therapeutic effect of Flucytosine. Consider therapy modification 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 Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Consider therapy modification Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Consider therapy modification Lumacaftor: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. Lumacaftor may increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy Palifermin: May enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Consider therapy modification P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy Ranolazine: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination Taxane Derivatives: May enhance the adverse/toxic effect of Anthracyclines. Taxane Derivatives may increase the serum concentration of Anthracyclines. Taxane Derivatives may also increase the formation of toxic anthracycline metabolites in heart tissue. Consider therapy modification Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. 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 cardiotoxic effect of Anthracyclines. Management: When possible, patients treated with trastuzumab should avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab. Monitor closely for cardiac dysfunction in patients receiving anthracyclines with trastuzumab. Consider therapy modification 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%: Cardiovascular: Edema (51%), cardiac arrhythmia (30%), cardiotoxicity (20%), hypotension (20%), hypertension (18%), chest pain (17%) Central nervous system: Headache (33%), fatigue (32%), sleep disorder (25%), chills (23%), dizziness (18%), delirium (16%), anxiety (14%) Dermatologic: Skin rash (54%), pruritus (15%) Endocrine & metabolic: Hyponatremia (grades 3/4: 6% to 14%) Gastrointestinal: Diarrhea ( 66%), nausea (47%), colitis ( 45%), mucositis (44%), constipation (40%), abdominal pain (33%), decreased appetite (29%), vomiting (24%), hemorrhoids (11%) Hematologic & oncologic: Anemia (100%), neutropenia (100%; grade 4 [prolonged]: 10% to 17%), thrombocytopenia (100%; grade 3 [prolonged]: 25% to 28%), hemorrhage (70%; grades 3 to 5: 10%), febrile neutropenia (68%; grades 3 to 5: 66%), petechia (11%) Hypersensitivity: Transfusion reaction (11%) Infection: Bacteremia (24%), fungal infection (18%), sepsis (11%) Local: Injection site reaction (16%; includes catheter and device site) Neuromuscular & skeletal: Musculoskeletal pain (38%) Ophthalmic: Visual impairment (11%) Renal: Renal insufficiency (11%) Respiratory: Cough (33%), dyspnea (32%), pneumonia (26%), hypoxia (18%), upper respiratory tract infection (18%), pleural effusion (16%) Miscellaneous: Fever (17%) 1% to 10%: Central nervous system: Hallucination (]} Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... 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