Lurbinectedin

What is Lurbinectedin?

• Lurbinectedin (Zepzelca) is an alkylating drug indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

What are the uses of this medicine?

• Lurbinectedin (Zepzelca) is used to treat adults with a kind of lung cancer called small cell lung cancer (SCLC).

Zepzelca may be used when your lung cancer:

• has spread to other parts of the body (metastatic), and
• you have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working.

How does this medicine work?

• Lurbinectedin is an alkylating drug that binds guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix towards the major groove.
• Adduct formation triggers a cascade of events that can affect the subsequent activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in perturbation of the cell cycle and eventual cell death.
• Lurbinectedin inhibited human monocyte activity in vitro and reduced macrophage infiltration in implanted tumors in mice.

Who Should Not Use this medicine ?

• This medicne have no usage limitations.

What drug interactions can this medicine cause?

• Avoid co-administration of Zepzelca with Strong or moderate CYP3A inhibitors and with Strong or moderate CYP3A inducers.

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• The recommended dosage of Zepzelca is 3.2 mg/m2 by intravenous infusion over 60 minutes every 21 days until disease progression or unacceptable toxicity.
• Consider premedication with corticosteroids and serotonin antagonists.

Administration

• Zepzelca is given by an intravenous (IV) infusion into a vein over 60 minutes.
• Zepzelca is usually given every 21 days.
• Before each treatment with Zepzelca, you may receive medicines to help prevent nausea and vomiting or make it less severe.
• Your healthcare provider will decide how long you will continue treatment with Zepzelca.
• Your healthcare provider may do certain tests during your treatment with Zepzelca to check you for side effects, and to see how well you respond to the treatment.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 4 mg lyophilized powder in a single-dose vial.

This medicine is available in fallowing brand namesː

• Zepzelca

What side effects can this medication cause?

Common possible side effects of this medicine include:

• tiredness
• low white and red blood cell counts
• increased kidney function blood test (creatinine)
• increased liver function blood tests
• increased blood sugar (glucose)
• nausea
• decreased appetite
• muscle and joint (musculoskeletal) pain
• low level of albumin in the blood
• constipation
• trouble breathing
• low levels of sodium and magnesium in the blood
• vomiting
• cough
• diarrhea

Zepzelca can cause serious side effects, including:

• Low blood cell counts: Low blood counts including low neutrophil counts (neutropenia) and low platelet counts (thrombocytopenia) are common with Zepzelca, and can also be severe.
• Liver problems:
• Increased liver function tests are common with Zepzelca, and can also be severe.

What special precautions should I follow?

• This medicine may cause myelosuppression. Monitor blood counts prior to each administration. Initiate treatment with Zepzelca only if baseline neutrophil count is ≥ 1,500 cells/mm3 and platelet count is ≥ 100,000/mm3. Withhold, reduce the dose, or permanently discontinue Zepzelca based on severity.
• This medicine may cause hepatotoxicity. Monitor liver function tests prior to initiating Zepzelca, periodically during treatment and as clinically indicated. Withhold, reduce the dose, or permanently discontinue Zepzelca based on severity.
• This medicine may cause fetal harm. Advise females and males of reproductive potential of the potential risk to a fetus and to use an effective method of contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Zepzelca can cause fetal harm when administered to a pregnant woman.
• There are no available data to inform the risk of Zepzelca use in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Zepzelca in pediatric patients have not been established.

What should I know about storage and disposal of this medication?

• Store refrigerated at 2° to 8°C (36° to 46°F).
• Zepzelca is a hazardous drug.
• Follow applicable special handling and disposal procedures.

• Dailymed label info on Lurbinectedin
• FDA Lurbinectedin