Trilaciclib (intravenous route)

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.

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.

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

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.

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

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.

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.

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