Registered Kenya · PPB

ERIBULIN MESYLATE

ERIBULIN MESYLATE

H2025/CTD12261/26498 0.88 MG PER 2ML GENERIC/BIOSIMILARS antineoplastic and immunomodulating agents INN generic

What it does

Eribulin is a medication used to treat certain types of breast cancer. It helps slow down the growth of cancer cells.

Commonly used for: breast cancer

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2025/CTD12261/26498
Registration date
-
Expiry date
2030 May 05
Status
Registered
Active ingredient
ERIBULIN MESYLATE
Dosage form
0.88 MG PER 2ML
Strength
-
Pack size
THE PROPOSED DRUG PRODUCT IS PACKED IN TUBULAR SULFUR TREATED TYPE I, 5 ML CLEAR GLASS VIALS STOPPERED WITH 13 MM CHLOROBUTYL RUBBER STOPPERS AND SEALED WITH 13 MM ALUMINUM FLIP-OFF SEALS
Therapeutic class
GENERIC/BIOSIMILARS
ATC class (WHO)
L01XX - Other antineoplastic agents
RxNorm RxCUI
1045453
Manufacturer / MAH
Eah Care
Country of origin
FOREIGN
Manufacturer location
Mogadishu Road, off Lunga Lunga Road, Industrial Area, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 19:17:42 · updated 2026-09-15 02:12:53

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Eribulin is a medication used to treat certain types of breast cancer. It helps slow down the growth of cancer cells.

What it treats

  • breast cancer

How it works

It works by interfering with the cancer cells' ability to divide and grow.

Who it's for

This medicine is for adults with specific types of breast cancer that have not improved with other treatments.

Cautions

  • • Be cautious if you are taking medications that can affect heart rhythm.
  • • Avoid medications that can cause nerve damage.
  • • Be careful with medications that can suppress bone marrow function.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Eribulin

BNF-referenced

Eribulin is an antineoplastic agent primarily used in the treatment of locally advanced or metastatic breast cancer. It is indicated for patients whose disease has progressed following at least one chemotherapy regimen, including treatments involving an anthracycline and a taxane. Eribulin is administered via intravenous injection and acts primarily through its impact on microtubule dynamics.

Indications

  • Locally advanced breast cancer
  • Metastatic breast cancer

Dosage

Adults: Administered on day 1 and day 8 of a 21-day cycle. Previous therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless the patient is unsuitable for these treatments.

Mechanism of action

Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates. This action leads to a tubulin-based antimitotic mechanism causing a G2/M cell-cycle block, disrupting mitotic spindles, and ultimately resulting in apoptotic cell death after prolonged mitotic blockage.

Pharmacodynamics

Eribulin exhibits linear pharmacodynamics, influencing cell division and growth by interfering with the normal function of microtubules, which are essential for mitosis.

Pharmacokinetics

Eribulin has a molecular formula of C40H59NO11. While specific pharmacokinetic parameters such as absorption, distribution, metabolism, and excretion are not detailed in the provided sources, it is understood that its administration is through intravenous injection, which allows for rapid distribution into the systemic circulation. Monitoring of hepatic function is advised during treatment.

Contra-indications

  • Congenital long QT syndrome

Adverse effects

  • Neurotoxicity
  • Myalgia
  • Neutropenia
  • Thrombocytopenia
  • Seizures
  • Pain
  • Dysphagia
  • Dysphasia
  • Fatigue
  • Fever
  • Headache
  • Dizziness
  • Chills
  • Diarrhea
  • Hypersensitivity reactions
  • Limb swelling
  • Lip swelling
  • Hepatic disorders
  • Hepatic failure
  • Pancreatitis
  • Chest pain
  • Respiratory disorders
  • Increased risk of infection

Interactions

  • Asparaginase may reduce the effectiveness of oral contraceptives, additional precautions (e.g., barrier method) are required.

Precautions

  • Monitor trough serum asparaginase levels 3 days after administration.
  • Monitor bilirubin, hepatic transaminases, and coagulation parameters before and during treatment.
  • Facilities for the management of anaphylaxis should be available.

Pregnancy

Manufacturer advises to avoid use during pregnancy due to potential risks associated with cytotoxic drugs.

Breast-feeding

Manufacturer advises to discontinue breastfeeding during treatment.

Storage

Store in a refrigerator (2–8°C); consult product literature for storage conditions after reconstitution and dilution.

Formulations

  • Powder for solution for injection (Eribulin)
BNF 85 (British National Formulary) p.1041 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Eribulin

PubChem CID 11354606

Molecular formula: C40H59NO11

Mechanism of action

Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates. Eribulin exerts its effects via a tubulin-based antimitotic mechanism leading to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage. [FDA]

Pharmacodynamics

Linear

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.