Provide your patients comprehensive access-related support

Cosela Cares

PERMANENT J CODE

Effective: 10/1/2021

HCPCS Level II code1:

J1448 Injection, trilaciclib, 1 mg

Patient Support Program

Call us with questions at 1-833-418-6663, fax to 1-833-329-4121, or email us at enroll@COSELAcares.com

Your Resource for Access and Affordability Solutions

COSELA Cares™ offers a suite of solutions to help you address access and reimbursement hurdles:

Benefits verification to confirm patient coverage and out-of-pocket responsibilities

Payor-specific guidance for prior authorizations and appeals

Assistance navigating insurance-related delays or coverage denials

Providing resources that connect eligible patients, regardless of insurance type, to appropriate support options for high deductibles, copays, or coinsurance*

Help eligible patients who meet program criteria access COSELA treatment and support resources

* COSELA CaresTM provides informational support only and does not submit claims or perform administrative services on behalf of providers. Program participation does not guarantee insurance coverage, product access, or reimbursement.

Eligibility and restrictions apply.

Enroll Patients in Commercial Copay Program >
Nurse with patient

Simple COSELA Cares™ Enrollment Process

Call us with questions at 1-833-418-6663, fax to
1-833-329-4121, or email us at enroll@COSELAcare.com

COSELA Cares enrollment form
Complete and submit the form to enroll patients in COSELA Cares™
Download the Enrollment Form
Fax the form to
1-833-329-4121

Submitting the completed form will initiate a benefits investigation that includes coverage status, prior authorization requirements, and patient out-of-pocket costs. This information will be provided to your practice.†

†Enrollment does not guarantee benefits.

Resources to Make Coverage and Reimbursement Easier

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

  • COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

To report suspected adverse reactions, contact Pharmacosmos Therapeutics at 1-888-828-0655 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATION

COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

  • COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

WARNINGS AND PRECAUTIONS

Injection-Site Reactions, Including Phlebitis And Thrombophlebitis

  • COSELA administration can cause injection-site reactions, including phlebitis and thrombophlebitis, which occurred in 56 (21%) of 272 patients receiving COSELA in clinical trials, including Grade 2 (10%) and Grade 3 (0.4%) adverse reactions. Monitor patients for signs and symptoms of injection-site reactions, including infusion-site pain and erythema during infusion. For mild (Grade 1) to moderate (Grade 2) injection-site reactions, flush line/cannula with at least 20 mL of sterile 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP after end of infusion. For severe (Grade 3) or life-threatening (Grade 4) injection-site reactions, stop infusion and permanently discontinue COSELA. Injection-site reactions led to discontinuation of treatment in 3 (1%) of the 272 patients.

Acute Drug Hypersensitivity Reactions

  • COSELA administration can cause acute drug hypersensitivity reactions, which occurred in 16 (6%) of 272 patients receiving COSELA in clinical trials, including Grade 2 reactions (2%). Monitor patients for signs and symptoms of acute drug hypersensitivity reactions. For moderate (Grade 2) acute drug hypersensitivity reactions, stop infusion and hold COSELA until the adverse reaction recovers to Grade ≤1. For severe (Grade 3) or life-threatening (Grade 4) acute drug hypersensitivity reactions, stop infusion and permanently discontinue COSELA.

Interstitial Lung Disease/Pneumonitis

  • Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinases (CDK)4/6 inhibitors, including COSELA, with which it occurred in 1 (0.4%) of 272 patients receiving COSELA in clinical trials. Monitor patients for pulmonary symptoms of ILD/pneumonitis. For recurrent moderate (Grade 2) ILD/pneumonitis, and severe (Grade 3) or life-threatening (Grade 4) ILD/pneumonitis, permanently discontinue COSELA.

Embryo-Fetal Toxicity

  • Based on its mechanism of action, COSELA can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use an effective method of contraception during treatment with COSELA and for at least 3 weeks after the final dose.

ADVERSE REACTIONS

  • Serious adverse reactions occurred in 30% of patients receiving COSELA. Serious adverse reactions reported in >3% of patients who received COSELA included respiratory failure, hemorrhage, and thrombosis.
  • Fatal adverse reactions were observed in 5% of patients receiving COSELA. Fatal adverse reactions for patients receiving COSELA included pneumonia (2%), respiratory failure (2%), acute respiratory failure (<1%), hemoptysis (<1%), and cerebrovascular accident (<1%).
  • Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received COSELA. Adverse reactions leading to permanent discontinuation of any study treatment for patients receiving COSELA included pneumonia (2%), asthenia (2%), injection-site reaction, thrombocytopenia, cerebrovascular accident, ischemic stroke, infusion-related reaction, respiratory failure, and myositis (<1% each).
  • Infusion interruptions due to an adverse reaction occurred in 4.1% of patients who received COSELA.
  • The most common adverse reactions (≥10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

DRUG INTERACTIONS

  • COSELA is an inhibitor of OCT2, MATE1, and MATE-2K. Co-administration of COSELA may increase the concentration or net accumulation of OCT2, MATE1, and MATE-2K substrates in the kidney (e.g., dofetilide, dalfampridine, and cisplatin).

To report suspected adverse reactions, contact Pharmacosmos Therapeutics at 1-888-828-0655 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This information is not comprehensive. Please see the Full Prescribing Information.