HOVID GEFITINIB TABLETS 250 MG [SIN15984P]

Product Info

HOVID GEFITINIB TABLETS 250 MG

[SIN15984P]

Indication

INDICATIONS
Hovid Gefitinib is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK.

Dosing

DOSAGE AND ADMINISTRATION
Treatment with Hovid Gefitinib should be initiated and supervised by a physician experienced in the use of anti-cancer therapies.

Dosage
The recommended dosage of Hovid Gefitinib is one 250 mg tablet once a day. If a dose is missed, it should be taken as soon as the patient remembers. If it is less than 12 hours to the next dose, the patient should not take the missed dose. Patients should not take a double dose (two doses at the same time) to make up for a forgotten dose.

Hepatic impairment
No dosage adjustment is required in patients with moderate to severe hepatic impairment due to liver metastases.

Patients with moderate to severe hepatic impairment (Child-Pugh B or C) due to cirrhosis have increased plasma concentrations of gefitinib. These patients should be closely monitored for adverse events. Plasma concentrations were not increased in patients with elevated aspartate transaminase (AST), alkaline phosphatase or bilirubin due to liver metastases.

Renal impairment
No dosage adjustment is required in patients with mild to moderate renal impairment.

Elderly
No dose adjustment is required on the basis of patient age.

CYP2D6 poor metabolisers
No specific dose adjustment is recommended in patients with known CYP2D6 poor metaboliser genotype, but these patients should be closely monitored for adverse events.

Dose adjustment due to toxicity.
Patients with poorly tolerated diarrhea or skin adverse reactions may be successfully managed by providing a brief (up to 14 days) therapy interruption followed by reinstatement if the 250 mg dose.

In the event of acute onset or worsening of pulmonary symptoms (dyspnoea, cough, fever) gefitinib therapy should be interrupted and a prompt investigation of these symptoms should occur and appropriate treatment initiated. If interstitial lung disease is confirmed, gefitinib should be discontinued and the patient treated appropriately.

Patients who develop onset of new eye symptoms such as pain should be medically evaluated and managed appropriately, including gefitinib therapy interruption and removal of an aberrant eyelash if present. After symptoms and eye changes have resolved, the decision should be made concerning reinstatement of the 250 mg daily dose.

Method of administration
The tablet may be taken orally with or without food, at about the same time each day. The tablet can be swallowed whole with some water or if dosing of whole tablets is not possible, tablets may be administered as a dispersion in water (non-carbonated). No other liquids should be used. Without crushing it, the tablet should be dropped in half a glass of drinking water. The glass should be swirled occasionally, until the tablet is dispersed (this may take up to 20 minutes). The dispersion should be drunk immediately after dispersion is complete (i.e. within 60 minutes). The glass should be rinsed with half a glass of water, which should also be drunk. The dispersion can also be administered through a naso-gastric or gastrostomy tube.

Contraindications

CONTRAINDICATIONS
Known severe hypersensitivity to the active substance or to any of the excipients of this product.