Trilaciclib

Trilaciclib is a prescription medication used in adults with extensive-stage small-cell lung cancer to reduce chemotherapy-induced myelosuppression when administered before platinum/etoposide-containing or topotecan-containing regimens.

• Trilaciclib is available under the following different brand names: Cosela

Common side effects of trilaciclib include:

• fatigue
• low calcium levels (hypocalcemia)
• low potassium levels (hypokalemia)
• low phosphate levels (hypophosphatemia)
• increased aspartate aminotransferase
• headache
• pneumonia
• rash
• infusion-related reaction
• swelling of extremities
• abdominal pain
• blood clots
• high blood sugar (hyperglycemia)

Serious side effects of trilaciclib include:

• hives
• itching
• difficulty breathing
• swelling of the eyes, face, lips, tongue, or throat
• pain, redness, warmth, itching, swelling, bruising, or skin changes at the injection site
• 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 the mouth, or in your fingers and toes)
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in the chest, increased thirst or urination, numbness or tingling, muscle weakness, or limp feeling

Rare side effects of trilaciclib include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized cake for reconstitution

• 300 mg (provided as Trilaciclib dihydrochloride 349 mg)

Chemotherapy-induced myelosuppression

Adult dosage

• 240 mg/m2/dose IV completed within 4 hours before chemotherapy on each day chemotherapy is administered
• Interval between doses on sequential days should not be more than 28 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Trilaciclib has severe interactions with no other drugs
• Trilaciclib has serious interactions with at least 26 other drugs
• Trilaciclib has moderate interactions with no other drugs
• Trilaciclib has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of serious hypersensitivity to trilaciclib.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Trilaciclib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Trilaciclib?”

Cautions

• Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis reported with cyclin-dependent kinases (CDK)4/6 inhibitors, including Trilaciclib; monitor for symptoms (eg, cough, dyspnea, hypoxia)
• May cause fetal harm
• Injection-site reactions
  • Injection-site reactions (eg, phlebitis, thrombophlebitis) may occur
• Median time to onset: 15 days (from initiation); 1 day (preceding dose)
  • Median duration: 1 day
  • Monitor for signs and symptoms, including infusion-site pain and erythema during infusion
• Acute drug hypersensitivity reactions
  • May cause acute drug hypersensitivity reactions, including facial edema and urticaria
  • Median time to onset: 77 days (from initiation); 1 day (preceding dose)
• Median duration: 6 days
  • Monitor for signs and symptoms, including facial, eye, and tongue edema, urticaria, pruritus, and anaphylactic reactions
• Drug interaction overview
• Inhibitor of OCT2, MATE1, MATE-2K
• Certain OCT2, MATE1, and MATE-2K substrates
• Avoid coadministration
  • Trilaciclib may increase plasma and/or kidney concentrations of certain OCT2, MATE1, and MATE-2K substrates. (eg, dofetilide, dalfampridine, cisplatin)
  • Even minimal changes in concentration may lead to serious or life-changing toxicities

Pregnancy and Lactation

• Based on the mechanism of action, fetal harm may occur when administer to pregnant women
• No human or animal data are available
• Advise pregnant women of potential risks to the fetus
• Pregnancy tests are recommended for women of reproductive potential
• Contraception
  • Women of reproductive potential: Use effective contraception during treatment and for at least 3 weeks after the final dose
• Infertility
  • No studies performed
  • Based on animal studies, fertility may be impaired in women of reproductive potential
• Lactation
  • No data are available
  • Advice to not breastfeed during treatment and for at least 3 weeks after the last dose