Ibrance is not recommended:
- If you are allergic or have had an allergic reaction to Ibrance or ingredients in Ibrance
- If you are pregnant or breastfeeding
- For patients under 18 years of age
What are the Indications for Ibrance?
Ibrance is approved for the treatment of hormone reception (HR) +, human epidermal growth factor receptor 2 (HER2) – metastatic breast cancer in male and female adult patients.
Ibrance may be used with other therapy such as an aromatase inhibitor in postmenopausal women and men or fulvestrant in those that have completed hormonal therapy.
How is Ibrance used?
Ibrance should be stored in the original package between 68°F and 77°F (20°C and 25°C) away from heat and moisture.
Keep out of reach of children.
Take Ibrance by mouth, as directed by your doctor, with food at the same time every day. Swallow the capsule or tablet whole. Do not chew, split, or crush the capsule or tablet. Do not take any broken Ibrance capsule or tablet.
If you miss a dose, skip the missed dose and take your next dose as scheduled. If you threw up your dose, do not take another dose. Continue to take your next dose as scheduled.
Do not change your dosage and take more than what is prescribed, or stop using Ibrance without consulting with your doctor. If you took more than prescribed, contact your doctor immediately or seek emergency medical care.
Ibrance is available in capsule and tablet form in the following strength: 75 mg, 100 mg, 125 mg. Ibrance treatment is taken in a 28-day cycle. The recommended starting dose is 125 mg once daily for 21 days with 7 days off for a total of 28 days.
It’s important to understand that although Ibrance is FDA approved, it comes with side effects that may or may not affect you.
Before starting Ibrance, you should discuss possible side effects with your doctor or pharmacist.
Common Side Effects
Not all side effects require medical attention. As your body adjusts to Ibrance, side effects may go away. Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own.
- Loss of appetite
- Hair thinning or loss
- Sore mouth
Serious Side Effects
Severe adverse reactions while taking Ibrance may occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:
- Severe allergic reaction: severe rash or itching, swelling in the face, lips, tongue, or throat, rapid heartbeat, fainting or dizziness, or problems breathing or swallowing.
- Low white blood cell counts (neutropenia): weakness, dizziness, shortness of breath, bleeding easily, bruising easily, or nosebleeds.
- Lung problems: chest pain, cough, shortness of breath, or trouble breathing.
The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.
Warnings & Precautions
Before using Ibrance, tell your doctor or pharmacist:
- If you are allergic to Ibrance or any ingredients in Ibrance
- If you have any signs of infections including fever and chills
- If you have or have had liver or kidney problems
- If you are pregnant or plan to become pregnant
- If you are breastfeeding or plan to breastfeed
Low white blood cell counts (neutropenia)
Taking Ibrance may result in low white blood cell counts. This may lead to serious infections and death. Your doctor will check your white blood cell count before treatment with Ibrance and while you are taking Ibrance. Depending on your white blood cell count, your doctor may lower your dose or discontinue treatment of Ibrance.
Lung problems (pneumonitis)
Taking Ibrance may result in the inflammation of your lungs which may become severe and lead to death.
Signs and symptoms include shortness of breath, trouble breathing, chest pain, and cough. Contact your doctor immediately if you exhibit any of these symptoms.
Taking Ibrance can increase your risk of infections which can become serious and lead to death.
Signs and symptoms include chills, fever, confusion, or weakness. Contact your doctor immediately if you exhibit any of these symptoms.
Taking Ibrance may cause infertility problems in male patients resulting in the inability to conceive children. Contact your doctor if you have any questions or concerns regarding fertility.
Pregnant or Planning to Become Pregnant
Taking Ibrance while pregnant can impact the unborn baby and cause harm. If you are a female patient, your doctor will conduct a pregnancy test before starting treatment of Ibrance. If you are not pregnant but could become pregnant, you should use effective contraceptives during treatment of Ibrance and continue to use effective contraceptives up to 3 weeks after discontinuing Ibrance. If you become pregnant while on Ibrance, tell your doctor immediately.
If you are a male patient with female partners, you should use an effective contraceptive during treatment of Ibrance and continue to use effective contraceptives up to 3 months after discontinuing Ibrance. If your partner becomes pregnant while you are using Ibrance, tell your doctor right away.
Breastfeeding or Planning to Breastfeed
Studies have not been conducted to determine if Ibrance will pass through to human milk. However, due to severe possible side effects, breastfeeding should be discontinued while on treatment with Ibrance including up to 3 weeks after discontinuing Ibrance.
Interactions & Contraindications
Before using Ibrance, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.
Taking a CYP3A inhibitor with Ibrance increases the potency of Ibrance which can lead to an increased risk in side effects. CYP3A inhibitors should be avoided while taking Ibrance unless otherwise directed.
CYP3A inhibitors include itraconazole, ketoconazole, clarithromycin, voriconazole, telaprevir, nelfinavir, and ritonavir.
Consuming grapefruit while on treatment with Ibrance may increase the potency of Ibrance. This can lead to an increased risk of severe side effects including bleeding, nausea, vomiting, and low blood cells. Grapefruit should be avoided while on treatment with Ibrance unless otherwise directed.
Taking a CYP3A inducer with Ibrance may significantly reduce the potency of Ibrance. CYP3A inducers should be avoided while taking Ibrance unless otherwise directed.
CYP3A inducers include phenytoin, rifampin, carbamazepine, enzalutamide, and St John’s Wort.