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LONSURF

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Overview

What is LONSURF?

LONSURF contains trifluridine and tipiracil hydrochloride at a molar ratio of 1:0.5.

Trifluridine

Trifluridine, an antineoplastic thymidine-based nucleoside analogue, is described chemically as 2’-deoxy-5-(trifluoromethyl) uridine, and has the following structural formula:

Trifluridine has a molecular formula CHFNO and a molecular weight of 296.20. Trifluridine is a white crystalline powder, soluble in water, ethanol, 0.01 mol/L hydrochloric acid, 0.01 mol/L sodium hydroxide solution; freely soluble in methanol, acetone; sparingly soluble in 2-propanol, acetonitrile; slightly soluble in diethyl ether; and very slightly soluble in isopropyl ether.

Tipiracil hydrochloride

Tipiracil hydrochloride, a thymidine phosphorylase inhibitor, is described chemically as 5-chloro-6-[(2-iminopyrrolidin-1-yl)methyl]pyrimidine-2,4-(1,3)-dione monohydrochloride or 2,4(1,3)-Pyrimidinedione, 5-chloro-6-[(2-imino-1-pyrrolidinyl)methyl]-, hydrochloride (1:1), and has the following structural formula:

Tipiracil hydrochloride has a molecular formula CHClNO•HCl and a molecular weight of 279.12. Tipiracil hydrochloride is a white crystalline powder, soluble in water, 0.01 mol/L hydrochloric acid, and 0.01 mol/L sodium hydroxide; slightly soluble in methanol; very slightly soluble in ethanol; and practically insoluble in acetonitrile, 2-propanol, acetone, diisopropyl ether, and diethyl ether.

LONSURF Tablet (15 mg trifluridine/6.14 mg tipiracil)

Each film-coated tablet of LONSURF, for oral use, contains 15 mg of trifluridine and 6.14 mg of tipiracil equivalent to 7.065 mg of tipiracil hydrochloride as active ingredients. LONSURF tablets contain the following inactive ingredients: lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, and magnesium stearate.

LONSURF Tablet (20 mg trifluridine/8.19 mg tipiracil)

Each film-coated tablet of LONSURF, for oral use, contains 20 mg of trifluridine and 8.19 mg of tipiracil equivalent to 9.420 mg of tipiracil hydrochloride as active ingredients. LONSURF tablets contain the following inactive ingredients: lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, ferric oxide, and magnesium stearate.

Both film-coated tablets (LONSURF 15 mg/6.14 mg and 20 mg/8.19 mg) are imprinted with ink containing shellac, ferric oxide red, ferric oxide yellow, titanium dioxide, FD&C Blue No. 2 Aluminum Lake, carnauba wax, and talc.



What does LONSURF look like?



What are the available doses of LONSURF?

Tablets:

What should I talk to my health care provider before I take LONSURF?

How should I use LONSURF?

LONSURF is indicated for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

The recommended starting dose of LONSURF is 35 mg/m up to a maximum of 80 mg per dose (based on the trifluridine component) orally twice daily within one hour of completion of morning and evening meals on Days 1 through 5 and Days 8 through 12 of each 28-day cycle until disease progression or unacceptable toxicity. Round dose to the nearest 5 mg increment.

Do not take additional doses to make up for missed or held doses.

LONSURF is a cytotoxic drug. Follow applicable special handling and disposal procedures.


What interacts with LONSURF?

Sorry No Records found


What are the warnings of LONSURF?

Sorry No Records found


What are the precautions of LONSURF?

Sorry No Records found


What are the side effects of LONSURF?

Sorry No records found


What should I look out for while using LONSURF?

None.


What might happen if I take too much LONSURF?

The highest dose of LONSURF administered in clinical studies was 180 mg/m per day.

There is no known antidote for LONSURF overdosage.


How should I store and handle LONSURF?

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].LONSURF is a cytotoxic drug. Follow applicable special handling and disposal procedures. If stored outside of original bottle, discard after 30 days.Store at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].LONSURF is a cytotoxic drug. Follow applicable special handling and disposal procedures. If stored outside of original bottle, discard after 30 days.Store at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].LONSURF is a cytotoxic drug. Follow applicable special handling and disposal procedures. If stored outside of original bottle, discard after 30 days.Hydrocortisone Lotion USP, 2.5% is available as follows:2 fl oz (59 mL) bottle (NDC 45802--16)4 fl oz (118 mL) bottle (NDC 45802--26)Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed. Keep out of the reach of children.Manufactured By PerrigoBronx, NY 10457Distributed ByPerrigo®Allegan, MI 49010•www.perrigo.comRev 04-17: 3X116 RC F7Hydrocortisone Lotion USP, 2.5% is available as follows:2 fl oz (59 mL) bottle (NDC 45802--16)4 fl oz (118 mL) bottle (NDC 45802--26)Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed. Keep out of the reach of children.Manufactured By PerrigoBronx, NY 10457Distributed ByPerrigo®Allegan, MI 49010•www.perrigo.comRev 04-17: 3X116 RC F7Hydrocortisone Lotion USP, 2.5% is available as follows:2 fl oz (59 mL) bottle (NDC 45802--16)4 fl oz (118 mL) bottle (NDC 45802--26)Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed. Keep out of the reach of children.Manufactured By PerrigoBronx, NY 10457Distributed ByPerrigo®Allegan, MI 49010•www.perrigo.comRev 04-17: 3X116 RC F7Hydrocortisone Lotion USP, 2.5% is available as follows:2 fl oz (59 mL) bottle (NDC 45802--16)4 fl oz (118 mL) bottle (NDC 45802--26)Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed. Keep out of the reach of children.Manufactured By PerrigoBronx, NY 10457Distributed ByPerrigo®Allegan, MI 49010•www.perrigo.comRev 04-17: 3X116 RC F7Hydrocortisone Lotion USP, 2.5% is available as follows:2 fl oz (59 mL) bottle (NDC 45802--16)4 fl oz (118 mL) bottle (NDC 45802--26)Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed. Keep out of the reach of children.Manufactured By PerrigoBronx, NY 10457Distributed ByPerrigo®Allegan, MI 49010•www.perrigo.comRev 04-17: 3X116 RC F7Hydrocortisone Lotion USP, 2.5% is available as follows:2 fl oz (59 mL) bottle (NDC 45802--16)4 fl oz (118 mL) bottle (NDC 45802--26)Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed. Keep out of the reach of children.Manufactured By PerrigoBronx, NY 10457Distributed ByPerrigo®Allegan, MI 49010•www.perrigo.comRev 04-17: 3X116 RC F7Hydrocortisone Lotion USP, 2.5% is available as follows:2 fl oz (59 mL) bottle (NDC 45802--16)4 fl oz (118 mL) bottle (NDC 45802--26)Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed. Keep out of the reach of children.Manufactured By PerrigoBronx, NY 10457Distributed ByPerrigo®Allegan, MI 49010•www.perrigo.comRev 04-17: 3X116 RC F7Hydrocortisone Lotion USP, 2.5% is available as follows:2 fl oz (59 mL) bottle (NDC 45802--16)4 fl oz (118 mL) bottle (NDC 45802--26)Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed. Keep out of the reach of children.Manufactured By PerrigoBronx, NY 10457Distributed ByPerrigo®Allegan, MI 49010•www.perrigo.comRev 04-17: 3X116 RC F7Hydrocortisone Lotion USP, 2.5% is available as follows:2 fl oz (59 mL) bottle (NDC 45802--16)4 fl oz (118 mL) bottle (NDC 45802--26)Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed. Keep out of the reach of children.Manufactured By PerrigoBronx, NY 10457Distributed ByPerrigo®Allegan, MI 49010•www.perrigo.comRev 04-17: 3X116 RC F7Hydrocortisone Lotion USP, 2.5% is available as follows:2 fl oz (59 mL) bottle (NDC 45802--16)4 fl oz (118 mL) bottle (NDC 45802--26)Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed. Keep out of the reach of children.Manufactured By PerrigoBronx, NY 10457Distributed ByPerrigo®Allegan, MI 49010•www.perrigo.comRev 04-17: 3X116 RC F7Hydrocortisone Lotion USP, 2.5% is available as follows:2 fl oz (59 mL) bottle (NDC 45802--16)4 fl oz (118 mL) bottle (NDC 45802--26)Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed. Keep out of the reach of children.Manufactured By PerrigoBronx, NY 10457Distributed ByPerrigo®Allegan, MI 49010•www.perrigo.comRev 04-17: 3X116 RC F7


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

LONSURF consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase inhibitor, tipiracil, at a molar ratio 1:0.5 (weight ratio, 1:0.471). Inclusion of tipiracil increases trifluridine exposure by inhibiting its metabolism by thymidine phosphorylase.

Following uptake into cancer cells, trifluridine is incorporated into DNA, interferes with DNA synthesis and inhibits cell proliferation. Trifluridine/tipiracil demonstrated anti-tumor activity against wild-type and mutant human colorectal cancer xenografts in mice.

Non-Clinical Toxicology
None.

In Study 1, LONSURF caused severe and life-threatening myelosuppression (Grade 3-4) consisting of anemia (18%), neutropenia (38%), thrombocytopenia (5%) and febrile neutropenia (3.8%). One patient (0.2%) died due to neutropenic infection. In Study 1, 9.4% of LONSURF-treated patients received granulocyte-colony stimulating factors.

Obtain complete blood counts prior to and on Day 15 of each cycle of LONSURF and more frequently as clinically indicated. Withhold LONSURF for febrile neutropenia, Grade 4 neutropenia, or platelets less than 50,000/mm. Upon recovery resume LONSURF at a reduced dose. see

The following serious adverse reactions are discussed in detail in other sections of the labeling:

 

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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