Lonsurf

Lonsurf

Lonsurf

What is Lonsurf?

Lonsurf can be used to treat adults with:

• Darmkrebs, der sich auf andere Körperteile ausgebreitet hat (metastasiert), als Einzelwirkstoff oder in Kombination mit Bevacizumab bei Patienten, die zuvor mit anderen spezifischen Arten von Chemotherapie behandelt wurden
• metastasiertes Adenokarzinom des Magens oder des gastroösophagealen Übergangs, das zuvor mit mindestens zwei verschiedenen spezifischen Chemotherapieschemata behandelt wurde.

Lonsurf was first approved by the FDA on February 23, 2015.

Warnings

There are no contraindications to using Lonsurf.

Lonsurf affects your immune system and can lead to severe bone marrow suppression.You can get infections more easily, even serious or fatal infections. Call your doctor if you have fever, chills, body aches, or unusual bleeding or bruising.

Blood tests are required before and during treatment with Lonsurf and before and on day 15 of each cycle. Call your doctor immediately if you notice any signs of infection (fever, chills, body aches). The dosage of Lonsurf may need to be reduced.

Lonsurf should not be given to pregnant women as this is possibleharm an unborn child. If you are a woman of childbearing potential, your doctor may ask you to take a pregnancy test before starting Lonsurf. You should use effective contraception while taking it.

Before you take this medicine

To make sure Lonsurf is safe for you, tell your doctor if you have ever had:

• Kidney disease, or

• Liver disease.

You may need to have a negative pregnancy test before starting this treatment.

If kidney disease is severe, the dosage may need to be reduced. Do not use Lonsurf in patients with moderate or severe liver disease.

People over 65 are more likely to develop blood changes and other side effects.

Tipiracil and trifluridine can harm an unborn babyif the mother or father is using this medicine.

• If you are a woman,Do not use Lonsurf if you are pregnant. Use effective contraception to prevent pregnancy while you are using this medication and for at least 6 months after your last dose.

• If you are a man,Use effective contraception if your sexual partner may become pregnant. Continue using contraception for at least 3 months after the last dose.

• Tell your doctor immediately if pregnancy occurs while the mother or father is using Lonsurf.

You should not breast-feed while using this medicine and for at least 24 hours after the last dose.

How should I take Lonsurf?

Take Lonsurf exactly as your doctor has told you. Follow all instructions on your prescription label and read any medication guides or instructions for use. Your doctor may occasionally change your dose.

Blood tests are required before and during treatment with this medicine. The timing of these tests is very important.

The recommended dosage of Lonsurf is based on your body surface area (calculated based on your height and weight). The dosage is usually 35 mg/m2/dose, administered orally (by mouth) twice daily. Your doctor will calculate the right dose for you and your dosage may change if you gain or lose weight.

• Um die richtige Dosis zu erhalten, müssen Sie möglicherweise zwei oder mehr Tabletten unterschiedlicher Stärke und Farbe einnehmen. Befolgen Sie die Dosierungsanweisungen Ihres Arztes sehr sorgfältig. Lonsurf gibt es in zwei Stärken.
• Schlucken Sie die Tablette im Ganzen und zerdrücken, kauen oder zerbrechen Sie sie nicht.
• Lonsurf wird in einem 28-tägigen Behandlungszyklus verabreicht. Möglicherweise müssen Sie das Arzneimittel nur an bestimmten Tagen jedes Zyklus anwenden. Ihr Arzt wird festlegen, wie lange Sie mit diesem Arzneimittel behandelt werden sollen.
• Nehmen Sie Lonsurf zusammen mit einer Mahlzeit ein, und zwar innerhalb einer Stunde nach Beendigung der Morgen- und Abendmahlzeiten.
• Waschen Sie Ihre Hände sofort nach der Handhabung von Lonsurf-Tabletten. Pflegekräfte, die die Tabletten berühren oder damit umgehen, sollten Gummihandschuhe tragen.
• Die Dosierung von Tipiracil und Trifluridin richtet sich nach der Körperoberfläche (Größe und Gewicht). Ihr Dosisbedarf kann sich ändern, wenn Sie an Gewicht zunehmen oder abnehmen.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose. Do not take two doses at the same time.

If you vomit shortly after taking Lonsurf, do not take another dose. Wait until your next scheduled dose before taking the medicine again.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222.

What to avoid

Tipiracil and trifluridine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves when cleaning a patient's bodily fluids, handling contaminated trash or laundry, or changing diapers. Wash hands before and after taking off gloves. Wash soiled clothing and bedding separately from other laundry.

Side effects of Lonsurf

If necessary, get emergency medical helpSigns of an allergic reaction to Lonsurf:hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Call your doctor immediately if you have:

• low blood platelet levels- easy bruising, unusual bleeding, purple or red spots under the skin;

• low red blood cells (anemia)- pale skin, unusual tiredness, lightheadedness or shortness of breath, cold hands and feet; or

• low white blood cell count– Fever, mouth sores, sore skin, sore throat, cough, difficulty breathing.

If you experience certain side effects, your cancer treatments may be delayed or permanently stopped.

Serious side effects may be more likely in older adults.

Common side effects of Lonsurf may include:

• sich schwach oder müde fühlen
• Fieber
• Übelkeit, Erbrechen oder Durchfall
• Infektionen
• Magenschmerzen, Appetitlosigkeit
• Geschwüre im Mund
• Schmerzen beim Schlucken
• Haarausfall
• niedrige Blutkörperchenzahlen.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

What other drugs affect Lonsurf?

Other medications may interact with tipiracil and trifluridine, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

storage

Store the tablets in their original container at room temperature between 20°C and 25°C, protected from moisture and heat. Throw away any unused tablets after 30 days if not stored in the original container.

Keep away from children.

Ask your pharmacist how you can safely dispose of tablets you no longer need.

Ingredients

Effective ingredients: trifluridine and tipiracil hydrochloride.

Other ingredients: Lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, iron oxide (20 mg tablet only) and magnesium stearate.

embossing ink: Shellac, Iron Oxide Red, Iron Oxide Yellow, Titanium Dioxide, FD&C Blue No. 2 Aluminum Lake, Carnauba Wax and Talc.

Lonsurf is available in two strengths:

• 15 mg Trifluridin/6,14 mg Tipiracil
• 20 mg Trifluridin/8,19 mg Tipiracil.

Manufacturer

Taiho Pharmaceutical Co., Ltd for Taiho Oncology, Inc.

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