Ribociclib instructions, indications, usage and dosage, side effects

Indications: Ribociclib is a targeted therapy used to treat hormone receptor-positive, HER2-negative breast cancer that has spread (metastasized) or cannot be removed with surgery. Ribociclibis used in combination with other cancer drugs such as Latextrozole (Femara) or fulvestrant (Faslodex).

Usage and dosage:

Common dosage for adults with breast cancer:

Dose:600 mg (three 200 mg tablets) orally, once daily for 21 days, then 7 days off, for a total cycle of 28 days. Patients should take the tablets at approximately the same time each day, preferably in the morning.

When ribociclib is taken with an aromatase inhibitor, see the full prescribing information for the recommended dose of the aromatase inhibitor used.

When ribociclib is taken with fulvestrant, the recommended dose of fulvestrant is 500 mg on days 1, 15, 29 and then monthly thereafter. See full prescribing information for fulvestrant.

According to current clinical practice standards, premenopausal/perimenopausal women or men treated with ribociclib plus an aromatase inhibitor should be treated with a luteinizing hormone-releasing hormone (LHRH) agonist.

According to current clinical practice standards, men receiving ribociclib plus fulvestrant should be treated with a luteinizing hormone-releasing hormone (LHRH) agonist.

If a patient vomits after taking the medication or misses a dose, additional doses should not be taken that day. The next prescribed dose should be taken at your usual time. Tablets should be swallowed whole (tablets should not be chewed, crushed, or split before swallowing). Tablets should not be taken if they are broken, cracked, or otherwise incomplete.

Duration of treatment: Continue until disease progression or unacceptable toxicity

Dose adjustment: Dose should be adjusted based on drug interactions, adverse reactions, and hepatic injury.

Side effects: Common side effects of ribociclib are low white blood cells, infection, cough, nausea, vomiting, diarrhea, constipation, feeling tired, rash, headache; or hair loss.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty breathing, swelling of the face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple rash with blisters and swelling).

Seek medical treatment if you have a serious drug reaction that affects many parts of the body. Symptoms may include: rash, fever, swollen glands, muscle pain, severe weakness, unusual bruising, or yellowing of the skin or eyes.

Ribociclib may cause serious side effects. Contact your doctor right away if you have: fast or pounding heartbeat, chest fluttering, shortness of breathand sudden dizziness (like you might pass out); low white blood cell count—fever, mouth sores, skin sores, throat Pain, cough, trouble breathing; signs of lung inflammation - new or worsening cough, pain or difficulty breathing, wheezing, feeling short of breath even at rest; or liver problems - loss of appetite, upper abdominal pain, tiredness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes). If you experience certain side effects, your cancer treatment may be delayed or permanently stopped. This is not a complete list of side effects, and other side effects may occur.

Precautions: Ribociclib may cause serious side effects to your heart, liver, or lungs. If you have chest pain, fast or pounding heartbeat, difficulty breathing, cough (with or without mucus), sudden dizziness, pain in the upper right abdomen, loss of appetite, unusual bleeding or bruising, dark urine, or yellowing of the skin or eyes.

Concomitant use of tamoxifen may result in QT interval prolongation. Serious cutaneous adverse reactions (SCAR) may occur with this medicine.

Neutropenia (a decrease in neutropenia, a type of white blood cell) may occur with this medicine. You will have a complete blood count (CBC) before starting treatment with this drug, and your CBC will be monitored every 2 weeks for the first 2 cycles, at the beginning of each of the 4 subsequent cycles, and as clinically indicated.

You will need frequent medical tests while taking ribociclib. Depending on the results of these tests, your cancer treatment may be delayed. Tell your doctor if you have signs of infection, such as fever or chills. Ribociclib may cause harm to the fetus when taken by pregnant women.

Storage: Store ribociclib in original container at room temperature, away from moisture and heat.