Fulvestrant Ever Pharma

Monotherapy

Fulvestrant Ever Pharma is indicated for the treatment of hormone receptor (HR)-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

Combination Therapy with Palbociclib

​Fulvestrant Ever Pharma is indicated for the treatment of HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after endocrine therapy.

Fulvestrant Ever Pharma (Fulvestrant Ever Pharma) is an anti-estrogen medication. It works by blocking the actions of estrogen in the body. Certain types of breast cancer use estrogen to grow and multiply in the body.

Fulvestrant Ever Pharma is used to treat a certain type of hormone-related breast cancer in postmenopausal women, when the cancer has spread to other parts of the body after treatment with anti-estrogen medication.

Fulvestrant Ever Pharma is also used together with a medicine called palbociclib (Ibrance), to treat certain hormone-related breast cancer that has progressed or spread after treatment with hormonal therapy.

Adult Females (including the elderly): The recommended dose is 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose.

Special Population: Children and Adolescents: Fulvestrant Ever Pharma is not recommended for use in children or adolescents, as safety and efficacy have not been established in this age group.

Patients with Renal Impairment: No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance ≥30 mL/min). Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance <30 mL/min), and, therefore, caution is recommended in these patients.

Patients with Hepatic Impairment: No dose adjustments are recommended for patients with mild to moderate hepatic impairment. However, as Fulvestrant Ever Pharma exposure may be increased, Fulvestrant Ever Pharma should be used with caution in these patients. There are no data in patients with severe hepatic impairment.

Administration: Fulvestrant Ever Pharma should be administered as two consecutive 5 mL injections by slow intramuscular injection (1-2 minutes/injection), one in each buttock.

For detailed instructions for administration, see Instructions for Administration and Special Precautions for Disposal and Other Handling under Cautions for Usage.

See also:
What is the most important information I should know about Fulvestrant Ever Pharma?

Hypersensitivity to Fulvestrant Ever Pharma or to any of the excipients of Fulvestrant Ever Pharma. Pregnancy and lactation. Severe hepatic impairment.

Fertility, Pregnancy and Lactation: Women of Childbearing Potential: Patients of childbearing potential should be advised to use effective contraception while on treatment.

Pregnancy: Fulvestrant Ever Pharma is contraindicated in pregnancy. Fulvestrant Ever Pharma has been shown to cross the placenta after single IM doses in rat and rabbit. Studies in animals have shown reproductive toxicity including an increased incidence of foetal abnormalities and deaths. If pregnancy occurs while taking Fulvestrant Ever Pharma, the patient must be informed of the potential hazard to the foetus and potential risk for loss of pregnancy.

Breastfeeding: Breastfeeding must be discontinued during treatment with Fulvestrant Ever Pharma. Fulvestrant Ever Pharma is excreted in milk in lactating rats. It is not known whether Fulvestrant Ever Pharma is excreted in human milk. Considering the potential for serious adverse reactions due to Fulvestrant Ever Pharma in breastfed infants, use during lactation is contraindicated.

Fertility: The effects of Fulvestrant Ever Pharma on fertility in humans has not been studied.

Use Fulvestrant Ever Pharma as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Fulvestrant Ever Pharma. Talk to your pharmacist if you have questions about this information.
• Fulvestrant Ever Pharma is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Fulvestrant Ever Pharma at home, a health care provider will teach you how to use it. Be sure you understand how to use Fulvestrant Ever Pharma. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Fulvestrant Ever Pharma if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Fulvestrant Ever Pharma, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Fulvestrant Ever Pharma.

Fulvestrant Ever Pharma is used to treat certain types of breast cancer. Breast cancer cells need the hormone estrogen in order to grow. Fulvestrant Ever Pharma works by blocking the effect of estrogen, slowing tumor cell growth.

How to use Fulvestrant Ever Pharma intramuscular

Read the Patient Information Leaflet if available from your pharmacist before you start using Fulvestrant Ever Pharma and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is injected slowly into the buttock muscle as directed by your doctor. It is usually given every 2 weeks for the first 3 doses and then monthly thereafter.

The dosage is based on your medical condition. You will be instructed on whether to give your dose as one or two injections. To minimize discomfort, the medication can be taken out of the refrigerator up to 1 hour before the scheduled dose and allowed to reach room temperature.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. This medication is normally clear and colorless to yellow in color. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

See also:
What other drugs will affect Fulvestrant Ever Pharma?

There are no known drug-drug interactions. Fulvestrant Ever Pharma does not significantly inhibit any of the major CYP isoenzymes, including CYP 1A2, 2C9, 2C19, 2D6, and 3A4 in vitro, and studies of co-administration of Fulvestrant Ever Pharma with midazolam indicate that therapeutic doses of Fulvestrant Ever Pharma have no inhibitory effects on CYP 3A4 or alter blood levels of drug metabolized by that enzyme. Although Fulvestrant Ever Pharma is partly metabolized by CYP 3A4, a clinical study with rifampin, an inducer of CYP 3A4, showed no effect on the pharmacokinetics of Fulvestrant Ever Pharma. Also results from a healthy volunteer study with ketoconazole, a potent inhibitor of CYP 3A4, indicated that ketoconazole had no effect on the pharmacokinetics of Fulvestrant Ever Pharma and dosage adjustment is not necessary in patients co-prescribed CYP 3A4 inhibitors or inducers.

See also:
What are the possible side effects of Fulvestrant Ever Pharma?

The following adverse reactions are discussed in more detail in other sections of the labeling:

• Risk of Bleeding
• Increased Exposure in Patients with Hepatic Impairment
• Embryo-Fetal Toxicity

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice.

Monotherapy

Comparison of Fulvestrant Ever Pharma 500 mg and Fulvestrant Ever Pharma 250 mg

The following adverse reactions (ARs) were calculated based on the safety analysis of Study 1 comparing the administration of Fulvestrant Ever Pharma 500 mg intramuscularly once a month with Fulvestrant Ever Pharma 250 mg intramuscularly once a month. The most frequently reported adverse reactions in the Fulvestrant Ever Pharma 500 mg group were injection site pain (11.6% of patients), nausea (9.7% of patients) and bone pain (9.4% of patients); the most frequently reported adverse reactions in the Fulvestrant Ever Pharma 250 mg group were nausea (13.6% of patients), back pain (10.7% of patients) and injection site pain (9.1% of patients).

Table 1 lists adverse reactions reported with an incidence of 5% or greater, regardless of assessed causality, from Study 1.7

Table 1: Adverse Reactions in Study 1 ( ≥ 5% in Either Treatment Group)

In the pooled safety population (N=1127) from clinical trials comparing Fulvestrant Ever Pharma 500 mg to Fulvestrant Ever Pharma 250 mg, post-baseline increases of ≥ 1 CTC grade in either AST, ALT, or alkaline phosphatase were observed in > 15% of patients receiving Fulvestrant Ever Pharma. Grade 3-4 increases were observed in 1-2% of patients. The incidence and severity of increased hepatic enzymes (ALT, AST, ALP) did not differ between the 250 mg and the 500 mg Fulvestrant Ever Pharma arms.

Comparison of Fulvestrant Ever Pharma 250 mg and Anastrozole 1 mg in Combined Trials (Studies 2 and 3)

The most commonly reported adverse reactions in the Fulvestrant Ever Pharma and anastrozole treatment groups were gastrointestinal symptoms (including nausea, vomiting, constipation, diarrhea and abdominal pain), headache, back pain, vasodilatation (hot flashes), and pharyngitis.

Injection site reactions with mild transient pain and inflammation were seen with Fulvestrant Ever Pharma and occurred in 7% of patients (1% of treatments) given the single 5 mL injection (predominantly European Trial Study 3) and in 27% of patients (4.6% of treatments) given the 2 x 2.5 mL injections (North American Trial Study 2).

Table 2 lists adverse reactions reported with an incidence of 5% or greater, regardless of assessed causality, from the two controlled clinical trials comparing the administration of Fulvestrant Ever Pharma 250 mg intramuscularly once a month with anastrozole 1 mg orally once a day.

Table 2: Adverse Reactions in Studies 2 and 3 ( ≥ 5% from Combined Data)

Table 4: Laboratory Abnormalities in Study 4

Postmarketing Experience

For Fulvestrant Ever Pharma 250 mg, other adverse reactions reported as drug-related and seen infrequently ( < 1%) include thromboembolic phenomena, myalgia, vertigo, leukopenia, and hypersensitivity reactions including angioedema and urticaria.

Vaginal bleeding has been reported infrequently ( < 1%), mainly in patients during the first 6 weeks after changing from existing hormonal therapy to treatment with Fulvestrant Ever Pharma. If bleeding persists, further evaluation should be considered.

Elevation of bilirubin, elevation of gamma GT, hepatitis, and liver failure have been reported infrequently ( < 1%).

Fulvestrant Ever Pharma is a drug treatment of hormone receptor-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor.