Lonsurf Tablets

Lonsurf Tablets

5.00 out of 5
(1 customer review)

$2,370.00

Brand Name: Lonsurf

Active Ingredient: Trifluridine and Tipiracil

Manufactured by: Taiho Pharmaceuticals

Strength: 15mg/6.14mg and 20mg/8.19mg

Form: Tablets

Packing: Pack of 20 Tablets

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Description

Lonsurf Tablets Name of the medicinal product

Pharmaceutical form
Film-coated tablet (tablet).

Lonsurf 15 mg/6.14 mg film-coated tablets

The tablet is a white, biconvex, round, film-coated tablet, with a diameter of 7.1 mm and a thickness of 2.7 mm, imprinted with ’15’ on one side, and ‘102’ and ’15 mg’ on the other side, in grey ink.

Lonsurf 20 mg/8.19 mg film-coated tablets

The tablet is a pale red, biconvex, round, film-coated tablet, with a diameter of 7.6 mm and a thickness of 3.2 mm, imprinted with ’20’ on one side, and ‘102’ and ’20 mg’ on the other side, in grey ink.

Qualitative and quantitative composition
Lonsurf 15 mg/6.14 mg film-coated tablets

Each film-coated tablet contains 15 mg trifluridine and 6.14 mg tipiracil (as hydrochloride).

Excipient with known effect

Each film-coated tablet contains 90.735 mg of lactose monohydrate.

Lonsurf 20 mg/8.19 mg film-coated tablets

Each film-coated tablet contains 20 mg trifluridine and 8.19 mg tipiracil (as hydrochloride).

Excipient with known effect

Each film-coated tablet contains 120.980 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

**Therapeutic indications
Colorectal cancer

Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.

Gastric cancer

Lonsurf is indicated as mono therapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastrointestinal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Posology and method of administration
Lonsurf should be prescribed by physicians experienced in the administration of anticancer therapy.

Posology

The recommended starting dose of Lonsurf in adults is 35 mg/m2/dose administered orally twice daily on Days 1 to 5 and Days 8 to 12 of each 28-day cycle as long as benefit is observed or until unacceptable toxicity occurs (see section 4.4).

The dosage is calculated according to body surface area (BSA) (see Table 1). The dosage must not exceed 80 mg/dose.

If doses were missed or held, the patient must not make up for missed doses.

Special warnings and precautions for use
Bone marrow suppression

Lonsurf caused an increase in the incidence of myelosuppression including anaemia, neutropenia, leukopenia, and thrombocytopenia.

Complete blood cell counts must be obtained prior to initiation of therapy and as needed to monitor toxicity, but at a minimum, prior to each treatment cycle.

Treatment must not be started if the absolute neutrophil count is < 1.5 ×109/L, if the platelet counts are < 75× 109/L, or if the patient has an unresolved Grade 3 or 4 non-haematological clinically relevant toxicity from prior therapies.

Serious infections have been reported following treatment with Lonsurf (see section 4.8). Given that the majority were reported in the context of bone marrow suppression, the patient’s condition should be monitored closely, and appropriate measures, such as antimicrobial agents and granulocyte-colony stimulating factor (G-CSF), should be administered as clinically indicated. In RECOURSE and TAGS studies, 9.4% and 17.3% of patients in the Lonsurf group respectively received G-CSF mainly for therapeutic use.

Gastrointestinal toxicity

Lonsurf caused an increase in the incidence of gastrointestinal toxicities including nausea, vomiting and diarrhoea.

Patients with nausea, vomiting, diarrhoea and other gastrointestinal toxicities should be carefully monitored, and anti-emetic, anti-diarrhoeal and other measures, such as fluid/electrolyte replacement therapy, should be administered as clinically indicated. Dose modifications (delay and/or reduction) should be applied as necessary (see section 4.2).

Renal impairment

Lonsurf is not recommended for use in patients with end-stage renal disease (creatinine clearance [CrCl] < 15 mL/min or requiring dialysis), as Lonsurf has not been studied in these patients (see section 5.2). The global incidence of adverse events (AEs) is similar in normal renal function (CrCl ≥ 90 mL/min), mild (CrCl = 60 to 89 mL/min) or moderate (CrCl = 30 to 59 mL/min) renal impairment subgroups. However, the incidence of serious, severe AEs and AEs leading to dose modification tends to increase with advancing levels of renal impairment. In addition, a higher exposure of trifluridine and tipiracil hydrochloride was observed in patients with moderate renal impairment, compared with patients with normal renal function or patients with mild renal impairment (see section 5.2). Patients with severe renal impairment (CrCl = 15 to 29 mL/min) and adjusted starting dose of 20 mg/m2 twice daily had a safety profile consistent with the safety profile of Lonsurf in patients with normal renal function or mild renal impairment. Their exposure to trifluridine was similar to that of patients with normal renal function and their exposure to tipiracil hydrochloride was increased compared to patients with normal renal function, mild and moderate renal impairment (see sections 4.2 and 5.2). Patients with renal impairment should be monitored closely when being treated with Lonsurf; patients with moderate or severe renal impairment should be more frequently monitored for haematological toxicities. Hepatic impairment Lonsurf is not recommended for use in patients with baseline moderate or severe hepatic impairment (National Cancer Institute [NCI] Criteria Group C and D defined by total bilirubin > 1.5 x ULN), as a higher incidence of Grade 3 or 4 hyperbilirubinaemia is observed in patients with baseline moderate hepatic impairment, although this is based on very limited data (see section 5.2).

Proteinuria

Monitoring of proteinuria by dipstick urinalysis is recommended prior to starting and during therapy (see section 4.8).

Lactose intolerance

Lonsurf contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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1 review for Lonsurf Tablets

  1. 5 out of 5

    james

    i received goods today mnx
    Cheers

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