How To Change Ptcl Evo Package

Specialty Therapy Access Resources (STAR ^® ) is a reimbursement support, co-pay assistance, and patient assistance program designed to help patients and healthcare professionals in the United States gain appropriate access to the following products:

Important Safety Information and Full Prescribing Information

Important Safety Information for MARQIBO

Indications and Usage: MARQIBO (vinCRIStine sulfate LIPOSOME injection) is indicated for the treatment of adult patients with Philadelphia chromosome–negative (Ph‒) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following 2 or more anti-leukemia therapies. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

WARNING: FOR INTRAVENOUS USE ONLY – FATAL IF GIVIEN BY OTHER ROUTES

Marqibo is for intravenous use only and fatal if given by other routes. Death has occurred with intrathecal administration.
Marqibo (vinCRIStine sulfate LIPOSOME injection) has different dosage recommendations than vinCRIStine sulfate injection. Verify drug name and dose prior to preparation and administration to avoid overdosage.

Contraindications

MARQIBO is contraindicated in patients with demyelinating conditions, including Charcot-Marie-Tooth syndrome; in patients with hypersensitivity to vincristine sulfate or any of the other components of MARQIBO; and for intrathecal administration

Warnings and Precautions

Extravasation Tissue Injury: Extravasation causes tissue injury. If extravasation is suspected, discontinue infusion immediately and consider local treatment measures
Neurologic Toxicity: Sensory and motor neuropathy are common and cumulative. Monitor patients for peripheral motor and sensory, central and autonomic neuropathy before and after treatment; interrupt, reduce, or discontinue dosing based on severity. Patients with preexisting severe neuropathy should be treated with MARQIBO only after careful risk-benefit assessment
Myelosuppression: Neutropenia, thrombocytopenia, or anemia may occur. Monitor blood counts prior to each dose. Consider MARQIBO dose modification or reduction as well as supportive care measures if Grade 3 or 4 myelosuppression develops
Tumor Lysis Syndrome: Tumor lysis syndrome may occur in patients receiving MARQIBO. Anticipate, monitor for, and manage.
Constipation and Bowel Obstruction: Constipation, Ileus, bowel obstruction, and colonic pseudo-obstruction have occurred. A prophylactic bowel regimen should be instituted to mitigate potential constipation, bowel obstruction, and/or paralytic ileus
Fatigue: Severe fatigue can occur requiring dose delay, reduction, or discontinuation of MARQIBO
Hepatic Toxicity: Fatal liver toxicity and elevated levels of aspartate aminotransferase (AST) have occurred. Monitor hepatic liver function and modify or interrupt MARQIBO dosing for hepatic toxicity
Embryofetal Toxicity: MARQIBO can cause fetal harm when administered to pregnant women. Advise women of potential risk to fetus and to use effective contraception during treatment with MARQIBO and for 6 months after last dose. Advise male partners to use effective contraception during treatment with MARQIBO and for 3 months after last dose.

Adverse Events

The most commonly reported adverse reactions (incidence >30%) in clinical studies include constipation (57%), nausea (52%), pyrexia (43%), fatigue (41%), peripheral neuropathy (39%), febrile neutropenia (38%), diarrhea (37%), anemia (34%), decreased appetite (33%), and insomnia (32%)
A total of 76% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included febrile neutropenia (20%), pyrexia (13%), hypotension (7%), respiratory distress (6%), and cardiac arrest (6%)
Twenty-eight percent of patients experienced adverse reactions leading to treatment discontinuation. The most common adverse reactions that caused treatment discontinuation were peripheral neuropathy (10%), leukemia-related (7%), and tumor lysis syndrome (2%)
Deaths occurred in 23% of patients in study 1. The nonleukemia-related causes of death were brain infarct (1), intracerebral hemorrhage (2), liver failure (1), multisystem organ failure (2), pneumonia and septic shock (3), respiratory failure (4), pulmonary hemorrhage (1), and sudden cardiac death (1)

Drug Interactions

Concomitant use of strong CYP3A4 inhibitors may increase the concentration of vincristine and concomitant use of strong CYP3A4 inducer may decrease the concentration of vincristine. Avoid concomitant use of CYP3A4 inhibitors and inducers
Concomitant use with P-glycoprotein inhibitors or inducers should be avoided

Use in Specific Populations

The safety and effectiveness of MARQIBO in pediatric patients have not been established
It is not known whether MARQIBO is excreted in human milk
MARQIBO can cause fatal harm when administered to a pregnant women

Overdosage

The safety and effectiveness of MARQIBO in pediatric patients have not been established
It is not known whether MARQIBO is excreted in human milk
MARQIBO can cause fatal harm when administered to a pregnant women

Please click here to see the full Prescribing Information, including BOXED WARNINGS, for MARQIBO.

MAR-0169

Important Safety Information for EVOMELA

WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, and LEUKEMOGENICITY

Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) melphalan to oral melphalan have shown more myelosuppression with the IV formulation. Monitor hematologic laboratory parameters.
Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation of melphalan. Discontinue treatment with EVOMELA for serious hypersensitivity reactions.
Melphalan produces chromosomal aberrationsin vitroandin vivo. EVOMELA should be considered potentially leukemogenic in humans.

Contraindications

History of serious allergic reaction to melphalan.

Warnings and Precautions

Bone Marrow Suppression:For patients receiving EVOMELA as part of a conditioning regimen, myeloablation occurs in all patients. Do not begin the conditioning regimen if a stem cell product is not available for rescue. Monitor complete blood counts, provide supportive care for infections, anemia and thrombocytopenia until there is adequate hematopoietic recovery. For patients receiving EVOMELA as palliative treatment, if the bone marrow has been compromised by prior irradiation, prior chemotherapy or is recovering from chemotherapy, the risk of severe myelosuppression with EVOMELA is increased. Perform periodic complete blood counts during the course of treatment with EVOMELA. Provide supportive care for infections, bleeding, and symptomatic anemia.
Gastrointestinal Toxicity:For patients receiving EVOMELA as part of a conditioning regimen, nausea, vomiting, mucositis, and diarrhea may occur in over 50% of patients. Use prophylactic antiemetic medication. Provide supportive care for nausea, vomiting, diarrhea, and mucositis. The frequency of grade 3/4 mucositis in clinical studies was 13%. Provide nutritional support and analgesics for patients with severe mucositis. For patients receiving EVOMELA as palliative treatment, nausea and vomiting, diarrhea, and oral ulceration may occur. Use prophylactic antiemetics. Provide supportive care for nausea, vomiting, diarrhea and mucositis.
Hepatotoxicity:Hepatic disorders ranging from abnormal liver function tests to clinical manifestations such as hepatitis and jaundice have been reported after treatment with melphalan. Hepatic veno-occlusive disease has also been reported. Monitor liver chemistries.
Hypersensitivity:Acute hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received an intravenous formulation of melphalan. Symptoms may include urticaria, pruritus, edema, and skin rashes and, in some patients, tachycardia, bronchospasm, dyspnea, and hypotension. Discontinue treatment with EVOMELA for serious hypersensitivity reactions.
Secondary Malignancies:Secondary malignancies such as myeloproliferative syndrome or acute leukemia have been reported in multiple myeloma patients treated with melphalan-containing chemotherapy regimens. The potential benefit of EVOMELA therapy must be considered against the possible risk of the induction of a secondary malignancy.
Embryo-Fetal Toxicity:EVOMELA can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to avoid pregnancy during and after treatment with EVOMELA. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, advise the patient of potential risk to the fetus.
Infertility:Melphalan-based chemotherapy regimens have been reported to cause suppression of ovarian function in premenopausal women, resulting in persistent amenorrhea in approximately 9% of patients. Reversible or irreversible testicular suppression has also been reported.

Adverse Reactions

The most common adverse reactions observed in at least 50% of patients with multiple myeloma treated with EVOMELA were neutrophil count decreased (100%), white blood cell count decreased (100%), lymphocyte count decreased (98%), platelet count decreased (98%), diarrhea (93%), nausea (90%), fatigue (77%), hypokalemia (74%), anemia (66%), and vomiting (64%).
For myeloablative conditioning in multiple myeloma patients undergoing ASCT, twelve (20%) patients experienced a treatment emergent serious adverse reaction while on study. The most common serious adverse reactions (>1 patient, 1.6%) were pyrexia, hematochezia, febrile neutropenia, and renal failure. Treatment-related serious adverse reactions reported in >1 patient were pyrexia (n=2, 3%), febrile neutropenia (n=2, 3%), and hematochezia (n=2, 3%).
In a randomized clinical trial studying the palliative treatment of patients with multiple myeloma, severe myelotoxicity (WBC ≤1,000 and/or platelets ≤25,000) was more common in the IV melphalan arm (28%) than in the oral melphalan arm (11%).
In this randomized study, the rate of severe leukopenia in the IV arm in the patients with BUN over 30 mg/dL decreased from 50% (8/16) to 11% (3/28) after 50% reduction in IV melphalan dose. In addition, the incidence of drug-related death in the IV arm decreased from 10% (8/77) to 3% (3/108) after this dose reduction. This compares to an overall 1% (1/100) incidence of drug-related death in the oral melphalan arm.

Drug Interactions

No formal drug interaction studies have been conducted. When nalidixic acid and IV melphalan are given simultaneously, the incidence of severe hemorrhagic necrotic enterocolitis has been reported to increase in pediatric patients.

Use in Specific Populations

Lactation:It is not known whether melphalan is present in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from melphalan, breastfeeding is not recommended during treatment with EVOMELA.
Patients with Renal Impairment:For palliative treatment, consider dose reduction for patients with renal impairment receiving EVOMELA. Bone marrow suppression has been observed in patients with BUN levels ≥30 mg/dL. A 50% reduction in the IV melphalan dose decreased the incidence of severe bone marrow suppression in the latter portion of this study.

Please click here for full Prescribing Information, including BOXED WARNINGS, for EVOMELA.

EVO-0246

Adverse Drug Reaction (ADR) Reporting: Please report all adverse events suspected to have a causal relationship with Acrotech Biopharma's Products, using the contact number listed on each product's package insert. Adverse events not associated with the use of Acrotech's products, e.g., Disease Progression, or requests for discontinuing drug supply due to patient deaths not associated with the use of Acrotech's Products, should not be reported as ADRs.

Acrotech Biopharma, LLC does not guarantee coverage and/or reimbursement for its products. Coverage, coding, and reimbursement policies vary significantly by payer, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. Healthcare professionals should always verify coverage, coding, and reimbursement guidelines on a payer and patient-specific basis. Acrotech Biopharma, LLC. reserves the right to change eligibility guidelines, terminate, or modify the STAR program at any time for any reason.

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