Product Description

1. Technical Specifications

---

2. Product Description

Adcetris 50mg Injection contains Brentuximab Vedotin, an antibodydrug conjugate (ADC).
It consists of a CD30-directed monoclonal antibody linked to monomethyl auristatin E (MMAE), a microtubule-disrupting agent.
Once it binds to CD30-positive cancer cells, the conjugate is internalized, releasing MMAE and causing cell cycle arrest and apoptosis.

It is used in the treatment of Hodgkin lymphoma, systemic anaplastic large cell lymphoma, and other CD30-positive malignancies.

---

3. Product Highlights

---

4. Therapeutic Uses

• Hodgkin Lymphoma (HL):

  • Relapsed or refractory cases after autologous stem cell transplant.

  • As consolidation therapy post-transplant in high-risk patients.

• Systemic Anaplastic Large Cell Lymphoma (sALCL): Relapsed or refractory.

• Peripheral T-cell Lymphoma (PTCL): In combination with chemotherapy (first-line in some regimens).

• Cutaneous T-cell Lymphoma (CTCL): Including mycosis fungoides and primary cutaneous ALCL.

---

5. Side Effects

Common:

• Fatigue, fever, nausea, diarrhea

• Peripheral neuropathy (tingling, numbness, weakness)

• Neutropenia, anemia, thrombocytopenia

• Upper respiratory tract infections, cough

• Rash, pruritus

• Infusion-related reactions

Serious / Severe:

• Progressive multifocal leukoencephalopathy (PML) rare but fatal brain infection

• Severe neutropenia, febrile neutropenia

• Serious infections (bacterial, viral, fungal)

• Tumor lysis syndrome in high tumor burden patients

• Severe infusion reactions (anaphylaxis)

• Hepatotoxicity: elevated liver enzymes, hepatic failure (rare)

• Pulmonary toxicity: interstitial lung disease, pneumonitis

---

6. Precautions

• CBC Monitoring: Regularly check blood counts due to risk of myelosuppression.

• Neuropathy Monitoring: Dose modifications or discontinuation if neuropathy worsens.

• Infection Risk: Monitor for signs of serious/fatal infections.

• Liver Function: Monitor LFTs; caution in hepatic impairment.

• Pregnancy & Breastfeeding: Contraindicated (embryo-fetal toxicity). Effective contraception required during and after treatment.

• Drug Interactions: Avoid strong CYP3A4 inhibitors/inducers (e.g., ketoconazole, rifampicin).

• Infusion Reactions: Premedication (antihistamines, antipyretics, corticosteroids) may be considered in patients with prior infusion-related events.

Targeted Therapy for Lymphoma

Brentuximab Vedotin 50mg is an innovative targeted therapy used in the management of specific types of lymphoma, offering renewed treatment options for adult patients. This medication is designed to work selectively on malignant cells, potentially improving response rates and patient outcomes when administered as directed by a doctor.


Strict Dosage and Administration Guidelines

The injection is to be given only by trained healthcare professionals according to strict dosage instructions outlined by the physician. Self-administration is not advised. Always follow your doctors guidance for frequency and quantity, as incorrect use can diminish effectiveness or increase risks.


Proper Storage Ensures Efficacy

For optimal results, Brentuximab Vedotin 50mg injection must be stored in a cool and dry environment. Appropriate storage prevents degradation of the medications active ingredients, ensuring it remains effective throughout its shelf life.