Pronunciation:

trye-la-SYE-klib

Brand Names:

• Cosela

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Hematopoietic

Pharmacologic—

Cyclin-Dependent Kinase Inhibitor

Uses of This Medicine:

Trilaciclib injection is used to help reduce myelosuppression (bone marrow problem) caused by certain cancer medicines (eg, platinum/etoposide, topotecan) to treat patients with extensive-stage small cell lung cancer (ES-SCLC).

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of trilaciclib injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of trilaciclib injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cisplatin
• Dalfampridine
• Dofetilide

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Liver disease, moderate or severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Lung problems—Use with caution. May make this condition worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. This medicine must be given slowly, so the needle will have to remain in place for at least 30 minutes. It is given within 4 hours before you receive your cancer treatment.

Missed dose—

Call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely and at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 weeks after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause serious injection-site reactions (eg, phlebitis, thrombophlebitis). Check with your doctor right away if you have bluish color, changes in skin color, or pain, tenderness, or swelling at the injection site.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, hives or welts, redness of the skin, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or tongue while you are using this medicine.

This medicine may cause lung or breathing problems (eg, interstitial lung disease, pneumonitis), which can be life-threatening. Check with your doctor right away if you have chest pain, chills, cough, fever, general feeling of discomfort or illness, thickening of bronchial secretions, or trouble breathing.

Talk with your doctor before using this medicine if you plan to have children. Some women who use this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the site

bleeding gums

blue lips, fingernails, or skin

blurred vision

bone pain

chest pain or tightness

chills

confusion

cough

coughing up blood

decreased urine

dizziness

dry mouth

fever

flushed, dry skin

fruit-like breath odor

general feeling of discomfort or illness

headache

increased menstrual flow or vaginal bleeding

increased hunger

increased thirst

increased urination

irregular, fast or slow, or shallow breathing

lack or loss of strength

loss of appetite

mood or mental changes

muscle cramps in the hands, arms, feet, legs, or face

nausea or vomiting

numbness and tingling around the mouth, fingertips, or feet

nosebleeds

paralysis

pinpoint red spots on the skin

prolonged bleeding from cuts

red or black, tarry stools

red or dark brown urine

seizures or tremors

sneezing

sore throat

stomach cramps or pain

sweating

swelling of the hands, ankles, feet, or lower legs

thickening of bronchial secretions

trouble breathing

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.