Lucielace is a prescription medicine to treat women who have gone through menopause and adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), and whose disease has progressed after endocrine therapy.

Your healthcare provider will perform a test to make sure that Lucielace is right for you.

It is not known if Lucielace is safe and effective in children. 

Lucielace is an estrogen receptor antagonist indicated for treatment of postmenopausal women or adult men, with ER positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

Before taking Lucielace, tell your healthcare provider about your entire medical conditions, including if you: have liver problems are pregnant or plan to become pregnant. Lucielace can harm your unborn baby.

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

To treat Estrogen Receptor (ER)-positive, Human Epidermal growth factor Receptor 2 (HER2)-negative, ESR-1 mutated, advanced or metastatic (cancer that has spread) breast cancer that has progressed after receiving endocrine treatment in men or in women who have already stopped menstruating (postmenopausal).

Take Lucielace exactly as your healthcare provider tells you.

Do not change your dose or stop taking Lucielace unless your healthcare provider tells you.

Select patients for treatment with Lucielace based on the presence of ESR1 mutations.

The recommended dosage of Lucielace is one 345 mg tablet taken orally, once daily, with food.

Take Lucielace 1 time each day, at about the same time each day.

Take Lucielace with food. Taking Lucielace with food may help reduce nausea and vomiting.

Swallow Lucielace tablets whole. Do not chew, crush or split the tablets before swallowing.

Do not take any Lucielace tablets that are broken, cracked, or that look damaged.

If you miss a dose of Lucielace or vomit after taking a dose of Lucielace, do not take another dose of Lucielace on that day. Skip the dose and take your next dose the following day at your regularly scheduled time.

Dose interruption, reduction, or permanent discontinuation may be required due to adverse reactions.

Increased fat (lipid) levels in your blood (hypercholesterolemia and hypertriglyceridemia). Your healthcare provider will do blood tests to check your lipid levels before and during your treatment with Lucielace.

Muscle and joint (musculoskeletal) pain

Nausea

Increased cholesterol and triglyceride levels in your blood

Increased liver function tests

Tiredness

Decreased red blood cell counts

Vomiting

Decreased salt (sodium) levels in your blood

Increased kidney function test

Decreased appetite

Diarrhea

Headache

Constipation

Stomach-area (abdominal) pain

Hot flush

Indigestion or heartburn

Your healthcare provider may decrease your dose, temporarily stop, or completely stop treatment with Lucielace, if you develop certain side effects.

Strong and Moderate CYP3A4 Inducers: Avoid concomitant use with Lucielace.

Strong and Moderate CYP3A4 Inhibitors: Avoid concomitant use with Lucielace.

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉).

Protect from moisture.

Keep out of the reach of children.

Dyslipidemia: Lucielace may cause hypercholesterolemia and hypertriglyceridemia. Monitor lipid profile prior to starting treatment and periodically thereafter.

Embryo-Fetal Toxicity: Lucielace can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception. 

Lactation: Advise not to breastfeed.

Hepatic impairment: Avoid use in patients with severe hepatic impairment (Child-Pugh C). Reduce the dosage for patients with moderate hepatic impairment (Child-Pugh B). 

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Lucielace for a condition for which it was not prescribed. Do not give Lucielace to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for more information about Lucielace that is written for health professionals.