LUCIUS Vandetanib (LuciVande) 300mg [Film-coated Tablets]

Prescribing Information Simulation

Disclaimer: This is a simulated summary based on the known pharmacological data of Vandetanib and generic drug manufacturing standards. It is intended for informational purposes only and does not replace the official prescribing information provided by Lucius Pharmaceutical or the advice of a qualified healthcare professional. Always consult a medical doctor for treatment decisions. The brand name "Caprelsa" is a registered trademark of AstraZeneca; the generic name is Vandetanib.

1. TRADE NAME

LuciVande (Vandetanib) 300mg Tablets

2. COMPOSITION

Each film-coated tablet contains:
Vandetanib 300 mg

3. PHARMACEUTICAL FORM

Film-coated tablet.

4. CLINICAL PARTICULARS

4.1 Therapeutic Indications

LuciVande (Vandetanib) is indicated for the treatment of symptomatic or progressive medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.

4.2 Posology and Method of Administration

Administration must be initiated and supervised by a physician experienced in the use of anticancer therapies. This drug is associated with serious, potentially fatal risks and is subject to a restricted distribution program.

• Recommended Dose: The recommended dose is 300 mg (one tablet) taken orally once daily.

• Administration: Can be taken with or without food.

• Tablet Intake: Tablets must be swallowed whole with water. Do not crush or chew the tablets.

• Dose Adjustment: Dose interruption or reduction is mandatory in patients who experience severe toxicities. The dose may be reduced to 200 mg or 100 mg daily.

  • Key toxicities requiring management: QTc prolongation, severe skin reactions, interstitial lung disease, severe hypertension, heart failure.

• Hepatic Impairment: Not recommended in patients with moderate to severe hepatic impairment.

• Renal Impairment: Use with caution in patients with mild to moderate renal impairment. Contraindicated in patients with severe renal impairment (CrCl <30 mL/min).

4.3 Contraindications

• Hypersensitivity to vandetanib or any excipient.

• Congenital long QT syndrome.

• Severe renal impairment (creatinine clearance <30 mL/min).

• Coadministration with drugs known to prolong the QT interval (e.g., class Ia/III antiarrhythmics) and with strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, St. John's Wort).

4.4 Special Warnings and Precautions (Boxed Warnings)

This drug carries significant risks that require rigorous monitoring and management.

• QT Prolongation and Torsades de Pointes:

  • Can cause dose-dependent prolongation of the QT interval, which may lead to Torsades de Pointes, a life-threatening arrhythmia, and sudden death.

  • Monitoring: ECGs and serum electrolytes (potassium, calcium, magnesium) must be obtained at baseline, at 2-4 weeks and 8-12 weeks after starting treatment, and every 3 months thereafter.

  • Action: Do not start therapy if QTcF >500 ms. Dose reduction or permanent discontinuation is required for QTc >500 ms during treatment.

• Serious Skin Reactions:

  • Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be fatal, have occurred.

  • Action: Permanently discontinue vandetanib for severe skin reactions.

• Interstitial Lung Disease (ILD/Pneumonitis):

  • Fatal events have been reported. Monitor for new or worsening pulmonary symptoms (e.g., dyspnea, cough, fever). Discontinue therapy for confirmed ILD.

• Other Major Warnings:

  • Ischemic Cerebrovascular Events: Increased risk of strokes and TIAs.

  • Heart Failure: Monitor for signs and symptoms (dyspnea, edema). Discontinue for heart failure.

  • Hypertension: Monitor blood pressure regularly. Control hypertension; interrupt therapy for severe hypertension.

  • Hemorrhage: Serious, including fatal, hemorrhagic events can occur.

  • Diarrhea: Can be severe. Manage with antidiarrheal agents; dose interruption/reduction may be needed.

  • Hypothyroidism: Monitor TSH levels; adjust thyroid replacement therapy as needed.

  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue therapy if diagnosed.

4.5 Interaction with other Medicinal Products

• QT-Prolonging Drugs: Contraindicated. Coadministration with drugs like amiodarone, disopyramide, moxifloxacin significantly increases arrhythmia risk.

• Strong CYP3A4 Inducers: Contraindicated. (e.g., rifampicin, phenytoin, carbamazepine, St. John's Wort) decrease vandetanib plasma concentration.

• Drugs Causing Electrolyte Imbalance: Use diuretics with caution due to risk of hypokalemia or hypomagnesemia, which exacerbate QT prolongation.

4.6 Pregnancy and Lactation

• Pregnancy: Based on mechanism, can cause fetal harm. Females of reproductive potential must use effective contraception during and for at least 4 months after treatment.

• Lactation: Advise not to breastfeed due to the potential for serious adverse reactions in the infant.

4.7 Undesirable Effects (Adverse Reactions)

Summary of selected adverse reactions:

• Very Common (≥1/10):

  • Diarrhea, nausea, vomiting, abdominal pain

  • Rash (including acneiform), dry skin, pruritus, photosensitivity

  • Hypertension, headache, fatigue

  • Decreased appetite

  • Prolonged QT interval

  • Corneal opacity

• Common (≥1/100 to <1/10):

  • Severe skin reactions (SJS/TEN)

  • Interstitial lung disease

  • Heart failure, ischemic stroke

  • Hemorrhage

  • Renal impairment

  • Blurred vision

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic Properties

• Mechanism of Action: Vandetanib is a multi-kinase inhibitor. It inhibits the tyrosine kinase activity of:

  • RET (a primary driver in MTC).

  • VEGFR (Vascular Endothelial Growth Factor Receptor), inhibiting angiogenesis.

  • EGFR (Epidermal Growth Factor Receptor), inhibiting tumor cell growth and survival.

6. PHARMACEUTICAL PARTICULARS

6.1 Shelf Life

• As stated on the packaging (typically 24-36 months).

6.2 Special Precautions for Storage

• Store below 30°C (86°F).

• Keep in the original package to protect from moisture and light.

6.3 Name and Address of the Marketing Authorization Holder

Lucius Pharmaceutical Co., Ltd.
Address: [Address would be listed here, e.g., Saphanthong Neua Village, Sisattanak District, Vientiane Capital, Lao P.D.R.]

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