FULVESTRANT

Background and Date of Approval

Fulvestrant is an anticancer medication approved for medical use on 25 April 2002.

Uses

Fulvestrant Injection has been developed to treat advanced and metastatic breast cancer in men and menopausal women who have stopped responding to other treatments.

How is it administered?

Fulvestrant is available as a 5ml prefilled syringe in doses 50mg and 250mg. The recommended dosage is 500 mg as two 5ml injections on the 1st, 15th, and 29th days and once a month thereafter. For patients with liver problems, the recommended dose is 250mg. Your physician will administer this medicine intramuscularly into the buttocks.

Side Effects

The common side effects that are likely to occur while you are on the treatment with Fulvestrant Injection are injection site pain, nausea, muscle, joint, and bone pain, headache, back pain, tiredness, pain in the arms, hands, legs, or feet, hot flashes, cough, vomiting, loss of appetite, weakness, shortness of breath, constipation, increased liver enzymes, and diarrhea. Fulvestrant Injection may also cause injection site-related nerve damage. Call your healthcare provider if you experience numbness, tingling, or weakness after taking this injection.

Warnings

It is unknown whether Fulvestrant Injection is safe and effective in children and patients with severe liver problems. During the Fulvestrant Injection treatment, your doctor may periodically monitor your complete blood count to prevent serious complications. Report to your doctor if you have a bleeding disorder, heart problem, liver disease, or kidney problem.

Precautions

Fulvestrant Injection may cause fertility problems in men and women. This injection is not recommended for pregnant women due to its ability to cause fetal harm. Inform your healthcare provider before starting this treatment if you are pregnant or planning to have a baby. Pregnancy testing is recommended for women of reproductive potential within at least 7 days before starting Fulvestrant treatment. Discuss effective contraceptive methods to use during and for one year after the last dose of Fulvestrant. There is no sufficient information regarding the impact of Fulvestrant Injection on breastfeeding. Tell your healthcare provider if you are a breastfeeding mother or planning to breastfeed your child.

Word of Advice

Fulvestrant may cause constipation; adequate water intake is recommended during treatment. A balanced diet should be maintained. If fatigue or weakness occurs, avoid driving or operating machinery. Use with caution if you have bleeding disorders or are taking anticoagulant medications.

References

Sagent Pharmaceuticals, Inc., [Revised on Oct 2019] [Accessed on 26th Aug 2022], https://www.sagentpharma.com/wp-content/uploads/2021/08/Fulvestrant-Injection_PI_April-2021.pdf KD Tripathi, Essentials of Medical Pharmacology, Estrogens, Progestins and Contraceptives, 8th Edition, 2019, 330-353.

Frequently Asked Questions

1. Is Fulvestrant Injection used as a monotherapy to treat cancer?

Fulvestrant Injection is prescribed alone if you have gone through menopause and your breast cancer is hormone receptor-positive and human epidermal growth factor receptor 2 (HER 2)-negative.

2. Is it safe for men and women of reproductive age to use Fulvestrant Injection?

Fulvestrant Injection may cause fertility problems in men and women. This injection is not recommended for pregnant women due to its ability to cause fetal harm. Inform your healthcare provider before starting this treatment if you are pregnant or planning to have a baby.

3. Is Fulvestrant Injection safe to use during breastfeeding?

There is no sufficient information regarding the impact of Fulvestrant Injection on breastfeeding. Tell your healthcare provider if you are a breastfeeding mother or planning to breastfeed your child.

4. Who should not receive Fulvestrant Injection?

Patients who are allergic to Fulvestrant or its ingredients should not receive Fulvestrant Injections.

5. How is Fulvestrant Injection administered?

Your physician will administer Fulvestrant Injection intramuscularly into the buttocks.

6. How would you know if you are allergic to Fulvestrant Injection?

Itching, hives, swelling of face, lips, tongue, throat, and breathing trouble indicate that you are allergic to Fulvestrant Injection. Report to your Healthcare provider right away if you experience any of these symptoms.

7. How to store Fulvestrant Injection?

Store Fulvestrant Injection in a refrigerator, protected from light.

Available Brands 34

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS