Cosela

Last updated on RxList: 7/22/2021
Cosela Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Cosela?

Cosela (trilaciclib) is a kinase inhibitor 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.

What Are Side Effects of Cosela?

Side effects of Cosela include:

Dosage for Cosela

The recommended dose of Cosela is 240 mg/m2 as a 30-minute intravenous infusion completed within 4 hours prior to the start of chemotherapy on each day chemotherapy is administered.

Cosela In Children

Safety and effectiveness of Cosela in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Cosela?

Cosela may interact with other medicines such as:

Tell your doctor all medications and supplements you use.

Cosela During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Cosela; it may harm a fetus. Pregnancy testing is recommended for females of reproductive potential prior to initiating Cosela. Female patients of reproductive potential are advised to use effective contraception during treatment with Cosela and for at least 3 weeks after the final dose. It is unknown if Cosela passes into breast milk. Because of the potential for serious adverse reactions in breastfed children, breastfeeding is not recommended while taking Cosela and for at least 3 weeks after the last dose.

Additional Information

Our Cosela (trilaciclib) for Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Lung cancer is a disease in which lung cells grow abnormally in an uncontrolled way. See Answer
Cosela Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching; difficult breathing; swelling of your eyes, face, lips, tongue, or throat.

Call your doctor at once if you have:

  • pain, redness, warmth, itching, swelling, bruising, or skin changes where the medicine was injected;
  • fever, chills, cough with mucus;
  • sudden chest pain, wheezing, dry cough, feeling short of breath;
  • low calcium level--muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes); or
  • low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Your trilaciclib treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • low levels of calcium or potassium;
  • headache;
  • breathing problems;
  • feeling tired; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cosela (Trilaciclib for Injection)

SLIDESHOW

Lung Cancer: Early Signs, Symptoms, Stages See Slideshow
Cosela Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the label:

  • Injection-Site Reactions, including phlebitis and thrombophlebitis [see WARNINGS AND PRECAUTIONS]
  • Acute Drug Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • ILD/Pneumonitis [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of COSELA was evaluated in Studies 1, 2, and 3 [see Clinical Studies]. Patients received COSELA 240 mg/m² by 30-minute intravenous infusion prior to chemotherapy on each chemotherapy day. The data described in this section reflect exposure to COSELA among 240 patients (122 patients in the trilaciclib group and 118 patients in the placebo group) being treated for extensive stage-small cell lung cancer (ES-SCLC) in 3 randomized, double-blind, placebo-controlled trials: 32 patients with treatment naive ES-SCLC received carboplatin (AUC 5 Day 1) + etoposide (100 mg/m² Days 1-3) every 21 days; 58 received carboplatin (AUC 5 Day 1) + etoposide (100 mg/m² Days 1-3) every 21 days + atezolizumab (1200 mg on Day 1) every 21 days; 32 patients with previously treated ES-SCLC received topotecan (1.5 mg/m² Days 1-5) every 21 days.

Study 1: COSELA Prior To Etoposide, Carboplatin, And Atezolizumab (E/P/A)

Patients With Newly Diagnosed ES-SCLC Not Previously Treated With Chemotherapy

Study 1 (G1T28-05; NCT03041311) was an international, randomized (1:1), double-blind, placebo-controlled study of COSELA or placebo administered prior to treatment with etoposide, carboplatin, and atezolizumab (E/P/A) for patients with newly diagnosed ES-SCLC not previously treated with chemotherapy. The data presented below are for the 105 patients who received study treatment.

Eighty-five percent of patients receiving COSELA and 91% receiving placebo completed 4 cycles of induction therapy.

Study 2: COSELA Prior To Etoposide And Carboplatin (E/P)

Patients With Newly Diagnosed ES-SCLC Not Previously Treated With Chemotherapy

Study 2 (G1T28-02; NCT02499770) was an international, randomized (1:1), double-blind, placebo-controlled study of COSELA or placebo administered prior to treatment with etoposide and carboplatin (E/P) for patients with newly diagnosed ES-SCLC not previously treated with chemotherapy. The data presented below are for the 75 patients who received study treatment.

Seventy-six percent of patients in the COSELA group and 87% of patients in the placebo group completed at least 4 cycles of therapy. The median duration of treatment was 6 cycles in each treatment group.

Study 3: COSELA Prior To Topotecan

Patients With ES-SCLC Previously Treated With Chemotherapy

Study 3 (G1T28-03; NCT02514447) was an international, randomized (2:1), double-blind, placebo-controlled study of COSELA or placebo administered prior to treatment with topotecan for patients with ES-SCLC previously treated with chemotherapy. The data presented below are for the 60 patients who received study treatment with the 1.5 mg/m² dose of topotecan.

Thirty-eight percent of patients receiving COSELA and 29% of patients receiving placebo completed 5 or more cycles of therapy. The median duration of treatment was 3 cycles in each treatment group.

Integrated Safety Analysis

The adverse reaction summary presented in Table 3 are pooled safety results from Studies 1, 2, and 3. The patients included in the pooling are those randomized patients that received at least 1 dose of COSELA (122 patients) or placebo (118 patients).

Seventy-one percent of patients receiving COSELA and 78% of patients receiving placebo completed at least 4 cycles of therapy. The median duration of treatment was the same (4 cycles) for patients receiving COSELA and placebo.

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.

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).

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%).

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. The most frequently reported Grade ≥3 adverse reaction (≥5%) in patients receiving COSELA occurring at the same or higher incidence than in patients receiving placebo was hypophosphatemia.

The most common adverse reactions reported in at least 5% of patients receiving COSELA with a ≥2% higher incidence compared to patients receiving placebo are shown in Table 3.

Table 3: Adverse Reactions in ≥5% Patients with SCLC Receiving COSELA (with ≥2% Higher Incidence in COSELA Compared to Placebo)

Adverse ReactionCOSELA
(N=122)
Placebo
(N=118)
All Gradesa (%)Grade ≥3 (%)All Gradesa (%)Grade ≥3 (%)
Fatigue343272
Hypocalcemiab24<121<1
Hypokalemiac226183
Hypophosphatemiad217162
Aspartate aminotransferase increasede17<114<1
Headache13090
Pneumonia10787
Rash9<160
Infusion-related reaction8020
Edema peripheral704<1
Abdominal pain upper7030
Thrombosis7322
Hyperglycemia6230
a Graded per NCI CTCAE v4.03x
b Hypocalcemia=calcium decreased (lab) or treatment-emergent adverse event (TEAE) preferred term 'Hypocalcemia'
c Hypokalemia=potassium decreased (lab) or TEAE preferred terms 'Hypokalemia,' 'Blood potassium decreased'
d Hypophosphatemia=phosphate decreased (lab) or TEAE preferred terms 'Hypophosphatemia,' 'Blood phosphorus decreased'
e Aspartate aminotransferase increased=aspartate aminotransferase increased (lab) or TEAE preferred term 'Blood aspartate aminotransferase increased'

Grade 3/4 hematological adverse reactions occurring in patients treated with COSELA and placebo included neutropenia (32% and 69%), febrile neutropenia (3% and 9%), anemia (16% and 34%), thrombocytopenia (18% and 33%), leukopenia (4% and 17%), and lymphopenia (<1% and <1%), respectively.

Read the entire FDA prescribing information for Cosela (Trilaciclib for Injection)

© Cosela Patient Information is supplied by Cerner Multum, Inc. and Cosela Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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