

Fulzos 250mg Injection (Fulvestrant)
Manufactured By
Hetero Healthcare Ltd
Pack Of
1
Salt Composition
Fulvestrant
Storage
2°C–8°C; do not freeze.
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Overview
Fulzos 250 mg Injection is an anti-hormonal drug that contains fulvestrant as an active ingredient. The medicine used in the treatment of hormone receptor-positive breast cancer in postmenopausal women by attaching to estrogen receptors and decreasing their numbers. Each 5 ml of injection contains 250 mg of fulvestrant injection dose.
However, the typical dosage for therapy is 500 mg and is administered in two 250 mg doses intramuscularly deep in both buttocks. In line with the patient's clinical status and prior treatment with hormonal drugs, a fulvestrant 250mg injection may be prescribed in combination with targeted drugs like CDK4/6 inhibitors. Therefore, patients are advised to use the medication under healthcare professionals.
Quick Product Facts
| Field | Publication wording |
|---|---|
| Brand | fulzos |
| Generic / Active Ingredient | Fulvestrant |
| Strength | 250 |
| Dosage Form | Injection |
| Manufacturer / Marketer | Hetero Healthcare Ltd |
| Pack Size | 1 |
| Prescription Required | Yes |
| Therapeutic Categories | Cancer Medicines |
| Uses | Breast Cancer |
Uses and Indications
Fulvestrant 250mg Injection is used in:
- ER-positive, HER2-negative advanced breast cancer
- ER-positive, HER2-negative metastatic breast cancer
The medicine is usually prescribed for postmenopausal women. Fulzos 250 mg Injection is usually used when the patient shows signs of progression despite previous endocrine therapy. It is also sometimes used in combination with target drugs, such as CDK4/6 inhibitors, depending on the patient's condition and treatment plan.
How Fulzos 250mg Injection Works
The mode of action for Fulvestrant Injection involves binding to the hormone receptors found on the breast cancer cells in order to inhibit their activity. The medicine also helps in breaking down and reducing the number of these hormone receptors, which decreases hormone-related signaling and can slow the growth of hormone-sensitive breast cancer cells.
Clinical Evidence for Fulzos 250mg Injection
CONFIRM: This research indicated that the 500mg dosage of fulvestrant injection was superior to the previously used 250mg dosage. Therefore, the 500mg dosage should be considered the standard dosage.
FALCON: Two Fulzos 250 mg Injection achieved superior disease control compared to anastrozole among the patients with advanced estrogen receptor-positive breast cancer that had never been treated with endocrine therapy before.
PALOMA-3: This study proved the advantage of administering two fulvestrant 250mg injection in combination with palbociclib to those individuals who no longer respond to their hormone therapy.
Side Effects of Fulzos 250mg Injection
The side effects might differ from one individual to another. Although some side effects are minor and short-lived, there are some symptoms that need immediate attention from a doctor:
Common / expected side effects
- Injection-site pain
- Nausea
- Fatigue
- Hot flushes
- Headache
- Bone/joint/muscle pain
- Elevated liver enzymes
Serious side effects
- Bleeding/haematoma after IM injection
- Severe hepatic reactions
- Hypersensitivity
- Sciatic nerve injury/neuropathic symptoms (rare)
Critical Safety Warning
DOSE-STRENGTH WARNING: Fulzos 250 mg is available in 250 mg injectable form. But, generally, the dosage of fulvestrant 250mg injection available on its label is 500 mg, and it is usually administered through two injections of 250 mg each. The dosages must always be verified by the doctor before being taken into consideration, without considering only the name or strength of the product.
Fulzos 250mg Injection Dosage and How To Take It
Clinical context | Typical labelled / protocol guidance |
Standard regimen | 500 mg is given on Day 1, Day 15, and Day 29, followed by one dose every month. |
How 500 mg is given | The 500 mg dose is usually given as two 250 mg/5 mL deep intramuscular (IM) injections, with one injection in each buttock. |
Combination therapy | Fulzos Injection may be used with targeted therapy, depending on the other medicine and the treatment plan prescribed by the doctor. |
Hepatic impairment | In patients with moderate liver problems, the dose may need to be adjusted based on the doctor’s assessment. |
Important: This is just a general guide for treatment. The physician will determine the correct dose, schedule, combination of drugs, dosage adjustment due to organ dysfunction, and the handling of side effects, depending on the individual patient.
Fulzos 250mg Injection Missed Dose
If the Fulzos 250 mg injection appointment is missed, please contact the oncology clinic for guidance on how to proceed. Never take additional injections to cover up the missed one. It will be decided by the medical professionals when to give your next dose, particularly when missing an injection during your first dosing cycle.
Safety Advice for Fulzos 250mg Injection
| Category | Status | Guidance |
|---|---|---|
| Pregnancy | Avoid | Fulzos 250 mg Injection may harm the unborn baby. However, patients are advised to consult with the doctor before starting the treatment. |
| Breastfeeding | Avoid | Fulvestrant 250mg may pass into breast milk, so breastfeeding may need to be avoided for the recommended period. |
| Liver | Monitor | Liver problems can affect how Fulzos 250 mg Injection is processed, so extra monitoring may be needed. |
| Bleeding risk | Caution | Fulvestrant Injection is administered deeply into the muscle, where it poses an increased risk of bleeding to people on blood thinners or with lower platelets in their blood. |
| Driving | Caution | Avoid Fulvestrant 250mg Injection as fatigue or dizziness may affect alertness and make driving unsafe. |
Monitoring During Fulzos 250mg Injection Treatment
In case of treatment, periodic monitoring will help the physician assess the efficiency, safety, and possible side effects of Fulvestrant 250mg injection:
- Evaluation of symptoms, physical examination, or imaging to assess the efficiency of the treatment.
- Monitoring of liver function if necessary.
- Checking the injection site for pain and bleeding.
- Evaluating ovarian suppression if applicable.
Fulzos 250mg Injection Fact Box
| Parameter | Verified / publication wording |
|---|---|
| Brand | Fulzos 250mg Injection |
| Generic | Fulvestrant |
| Strength | 250 mg/5 mL |
| Form | Deep IM injection |
| Manufacturer / Marketer | Hetero Healthcare Ltd |
| Pack | 1 x 5 mL presentation |
| Storage | 2°C–8°C; do not freeze. |
| Prescription | Required |
| Self-treatment | Not appropriate; follow specialist prescription |
| Major safety theme | DOSE-STRENGTH WARNING |
Fulzos 250mg Injection Drug Interactions
| Drug / Class | Risk | What To Do |
|---|---|---|
| Anticoagulants/antiplatelets | May increase the risk of bleeding from the IM injection. | The doctor should assess bleeding risk and use proper injection technique. |
| Targeted cancer partners | Side effects may increase when used in combination. | Follow the monitoring and safety advice for the other medicine. |
| Estradiol immunoassays | Some tests may give inaccurate results because of test interference. | Use suitable laboratory methods and interpret the results carefully. |
FAQs About Fulzos 250mg Injection
Is fulvestrant 250 mg injection the full standard dose?
Not usually. Usually, the dosage form of Fulzos 250mg Injection is normally a single strength, while the dose that is normally recommended for administration as a standard treatment dose is 500 mg. The 500 mg dose is normally administered in two 250 mg injections, administered in both buttocks.
Is fulvestrant Injection a chemotherapy?
Fulzos 250mg Injection is an endocrine treatment that functions through blocking and degrading estrogen receptors, thereby inhibiting the growth of hormone receptor-positive breast cancer cells. However, this drug cannot be considered a chemotherapeutic agent.
Why are two injections often given?
Two 250 mg injections are used to deliver 500 mg.
Can Fulzos Injection combined with palbociclib?
Yes. Fulzos 250mg Injection can be administered together with palbociclib to suitably selected patients with advanced or metastatic breast cancer that is positive for HR but negative for HER2. Combination therapy aims at attacking the tumor using different mechanisms and may prove effective in delaying the progression of the disease.
Why Is Liver Function Important With Fulzos 250mg?
The function of the liver is significant, as the condition of the liver will influence the way the fulvestrant injection is absorbed in the body. In cases of hepatic insufficiency, the drug can stay in the body for a long time depending on the evaluation of the doctor.
Can Fulzos Injection be self-injected?
No. Fulvestrant 250mg Injection is a deep IM injection, which is only administered by trained healthcare professionals in a hospital or clinical setting.
How Long Does Treatment With Fulzos 250mg Injection Continue?
The therapy using Fulzos injection typically lasts as long as the tumor stays under control and the drug is tolerated by the patient. This depends on how the tumor reacts to the treatment and the occurrence of any serious side effects.
References
- Nathan, M. R., & Schmid, P. (2017). A review of fulvestrant in breast cancer. Oncology and therapy, 5(1), 17-29. https://link.springer.com/article/10.1007/s40487-017-0046-2
- Turner, N. C., Slamon, D. J., Ro, J., Bondarenko, I., Im, S. A., Masuda, N., ... & Cristofanilli, M. (2018). Overall survival with palbociclib and fulvestrant in advanced breast cancer. New England journal of medicine, 379(20), 1926-1936. https://pubmed.ncbi.nlm.nih.gov/30345905/
- Hart, C. D., Migliaccio, I., Malorni, L., Guarducci, C., Biganzoli, L., & Di Leo, A. (2015). Challenges in the management of advanced, ER-positive, HER2-negative breast cancer. Nature reviews Clinical oncology, 12(9), 541-552. https://www.ovid.com/journals/ntrco/abstract/10.1038/nrclinonc.2015.99~challenges-in-the-management-of-advanced-er-positive?redirectionsource=fulltextview
- Howell, A., & Sapunar, F. (2011). Fulvestrant revisited: efficacy and safety of the 500-mg dose. Clinical breast cancer, 11(4), 204-210. https://www.sciencedirect.com/science/article/abs/pii/S1526820911000206
- McKeage, K., Curran, M. P., & Plosker, G. L. (2004). Fulvestrant: a review of its use in hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy. Drugs, 64(6), 633-648. https://pubmed.ncbi.nlm.nih.gov/21319872/
Marketer Details
Hetero Healthcare Ltd
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