Kisqali

Kisqali is a prescription medication used to treat certain forms of breast cancer. 

Kisqali belongs to a group of drugs called kinase inhibitors. Kinase inhibitors work by slowing or preventing cancer cell growth. 

This medication comes in tablet form and is taken by mouth once daily, with or without food. Do not chew, divide, or break Kisqali tablets. Swallow tablets whole. 

Common side effects of Kisqali include nausea, fatigue, and diarrhea. 

Kisqali is a prescription medication used to treat postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or metastatic breast cancer. Kisqali is given in combination with an aromatase inhibitor (i.e. letrozole) as initial endocrine-based therapy. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with Kisqali. See the “Kisqali Precautions” section. 

The most common side effects of Kisqali include:

• nausea
• tiredness
• diarrhea
• hair loss
• vomiting
• constipation
• headache
• back pain

Kisqali may cause fertility problems if you are male and take Kisqali. This may affect your ability to father a child. Talk to your health care provider if this is a concern for you.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Kisqali. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take: 

QT Prolonging Meds

• drugs that can cause an called Torsades des Point such as
  • certain medications including: procainamide, sotalol (Betapace), , dofetilide (Tikosyn), amiodarone (Nexterone, Pacerone, Cordarone), ibutilide (Corvert)
  • certain fluoroquinolone antibiotics including: levofloxacin (Levaquin), ciprofloxacin (Cipro), gatifloxacin (Zymar), moxifloxacin (Avelox)
  • certain macrolide antibiotics including: clarithromycin (Biaxin), erythromycin (EES, others)
  • certain azole antifungals including: ketoconazole (Nizoral), itraconazole (Sporanox, Onmel)
  • certain antidepressants including: amitriptyline, desipramine (Norpramin), imipramine ), doxepin (Silenor), fluoxetine (Prozac, Sarafem, Symbyax), sertraline (Zoloft), venlafaxine (Effexor XR)
  • certain antipsychotics including: haloperidol (Haldol), droperidol (Inapsine), quetiapine (Seroquel XR), thioridazine, ziprasidone (Geodon)
  • and other medications including: cisapride, sumatriptan (Treximet, Imitrex, Alsuma, Zecuity), zolmitriptan (Zomig, (Trisenox), dolasetron (Anzemet), and methadone (Methadone, Dolophine)

CYP3A4 Substrates

• medications that use the enzyme CYP3A4 such as budesonide (Entocort), cyclosporine (Neoral, Gengraf, Sandimmune), darifenacin (Enablex), dihydroergotamine (Migranal), fentanyl (Abstral, Fentora, Onsolis, Actiq), pimozide (Orap), quinidine (Cardioquin, Duraquin, Quinact), sirolimus (Rapamune), tacrolimus (Prograf), terfenadine (Seldane), fluticasone (Flovent HFA, Flonase), eletriptan (Relpax), lovastatin (Mevacor), quetiapine (Seroquel), sildenafil (Viagra, Revatio), and simvastatin (Zocor)

STRONG CYP3A4 inhibitors (blockers)

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), (Rescriptor), and

STRONG CYP3A4 inducers

• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort

This is not a complete list of Kisqali drug interactions. Ask your doctor or pharmacist for more information. 

Kisqali may cause serious side effects, including:

QT prolongation – This is a condition when changes in the electrical activity of your heart occur, causing irregular heartbeats that can be life threatening. Talk to your healthcare provider about other medicines you are taking before you start taking Kisqali. Tell your healthcare provider right away if you have any signs or symptoms of QT prolongation:

• feeling faint
• lightheadedness
• dizziness
• feeling like your heart is beating irregularly or quickly

Decline in liver function – Tell your healthcare provider about any signs or symptoms of liver damage, which include the following:

• loss of appetite or start losing weight (anorexia)
• nausea or vomiting
• feel tired
• stomach pain or tenderness
• dark urine or light colored stools
• yellowing of your skin or the whites of your eyes
• fever or rash

Low white blood cell count (neutropenia) – A low white blood cell count can cause you to get infections, which may be serious. Serious illness or death can happen if an infection is not treated right away when white blood cell counts are very low. Tell your doctor right away if you have any of the following signs or symptoms of an infection:

• fever
• shortness of breath
• pain or burning on urination
• chills

Embryo-fetal toxicity – Can cause harm to your unborn baby. Talk to your doctor if you become pregnant while being treated with Kisqali. Kisqali should not be used in pregnant women. 

Avoid eating pomegranate or grapefruit and avoid drinking pomegranate or grapefruit juice during treatment with Kisqali since these may increase the amount of Kisqali in your blood.

Before taking Kisqali, tell your doctor about all of your medical conditions. Especially tell your doctor if you: 

• have any heart problems, including heart failure, irregular heartbeats, and QT prolongation
• have ever had a heart attack
• have a slow heartbeat (bradycardia)
• have problems with the amount of potassium, calcium, phosphorus, or magnesium in your blood
• have fever, chills, or any other signs or symptoms of infection
• have liver problems
• have any other medical conditions
• are pregnant, or plan to become pregnant. Kisqali can harm your unborn baby
  • If you are able to become pregnant, your health care provider should do a pregnancy test before you start treatment with Kisqali.
  • Females who are able to become pregnant and who take Kisqali should use effective birth control during treatment and for at least 3 weeks after the last dose of Kisqali.
  • Talk to your health care provider about birth control methods that may be right for you during this time.
  • If you become pregnant or think you are pregnant, tell your health care provider right away.
• are breastfeeding or plan to breastfeed. It is not known if Kisqali passes into your breast milk. Do not breastfeed during treatment with Kisqali and for at least 3 weeks after the last dose of Kisqali

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Kisqali and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

Tell your health care provider if you are pregnant or plan to become pregnant. Kisqali can harm your unborn baby.

• If you are able to become pregnant, your health care provider should do a pregnancy test before you start treatment with Kisqali. 
• Females who are able to become pregnant and who take Kisqali should use effective birth control during treatment and for at least 3 weeks after the last dose of Kisqali. 
• Talk to your health care provider about birth control methods that may be right for you during this time. 
• If you become pregnant or think you are pregnant, tell your health care provider right away. 

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known whether Kisqali passes into your breast milk. Do not breastfeed during treatment with Kisqali and for at least 3 weeks after the last dose of Kisqali. 

• Take the recommended dose of Kiqali once each day at about the same time, preferably in the morning
• You can take Kisqali either with or without food
• Swallow Kisqali tablets whole with a glass of water. Do not chew, crush, or split the tablets
• Do not take any Kisqali tablets that are broken, cracked, or that look damaged
• Avoid pomegranate or pomegranate juice, and grapefruit or grapefruit juice while taking Kisqali
• If you miss a dose of Kisqali or vomit after taking a dose of Kisqali, do not take another dose on that day. Take your next dose at your regular time
• If you take too much Kisqali, call your doctor right away or go to the nearest hospital emergency room

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following: 

• other medical conditions you have
• how you respond to the medication

Kisqali is taken with hormone therapy:

• The recommended starting dose of Kisqali is 600 mg (three 200-mg tablets), taken once daily 
• Ask your doctor about the recommended dose of your hormone therapy 

For the first 3 weeks in a cycle, you’ll take your 3 Kisqali pills in combination with a hormone therapy. The fourth week, you won’t take any Kisqali pills—you’ll only take your hormone therapy. After the fourth week, your doctor may have you start the same cycle over again, or may adjust your dose if needed.

If you take too much Kisqali, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

Store Kisqali at room temperature: 68°F to 77°F (20°C to25°C). Keep this and all medicines out of the reach of children.