VALCHLOR- mechlorethamine hydrochloride gel

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

MECHLORETHAMINE (UNII: 50D9XSG0VR) (MECHLORETHAMINE - UNII:50D9XSG0VR)

Mevcut itibaren:

Actelion Pharmaceuticals US, Inc.

INN (International Adı):

MECHLORETHAMINE

Kompozisyon:

MECHLORETHAMINE 0.012 g in 60 g

Uygulama yolu:

TOPICAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

VALCHLOR is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. The use of VALCHLOR is contraindicated in patients with known severe hypersensitivity to mechlorethamine. Hypersensitivity reactions, including anaphylaxis, have occurred with topical formulations of mechlorethamine. Pregnancy Category D [see Warnings and Precautions (5.5) ] Risk Summary Mechlorethamine can cause fetal harm when administered to a pregnant woman. There are case reports of children born with malformations in pregnant women systemically administered mechlorethamine. Mechlorethamine was teratogenic in animals after a single subcutaneous administration. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Warnings and Precautions (5.5) ]. Animal Data Mechlorethamine caused fetal malformat

Ürün özeti:

VALCHLOR is supplied in 60g tubes of 0.016% w/w mechlorethamine as a clear gel [NDC 66215-016-60]. Prior to dispensing, store in the freezer at -13°F to 5°F (-25°C to -15°C). Advise patients that refrigerated storage is required once dispensed. VALCHLOR is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Yetkilendirme durumu:

New Drug Application

Bilgilendirme broşürü

Actelion Pharmaceuticals US, Inc.
----------
MEDICATION GUIDE
VALCHLOR® (val-klor)
(mechlorethamine) gel
Important information: VALCHLOR is for use on skin only. Do not get
VALCHLOR near or in your
eyes, mouth, or nose.
What is the most important information I should know about VALCHLOR?
Keep VALCHLOR away from your eyes, mouth, and nose.
•
If VALCHLOR gets in your eyes it can cause eye pain, burning,
swelling, redness, sensitivity to
light, and blurred vision. It may also cause blindness and permanent
injury to your eyes. If
VALCHLOR gets in your eyes, rinse your eyes right away for at least 15
minutes with a large
amount of water, normal saline, or an eye wash solution.
•
If VALCHLOR gets in your mouth or nose it can cause pain, redness, and
ulcers. Rinse the
affected area right away for at least 15 minutes with a large amount
of water.
Get medical help right away if VALCHLOR gets in your eyes, mouth, or
nose. Talk with your healthcare
provider before using VALCHLOR about how to get medical help.
What is VALCHLOR?
VALCHLOR is a prescription medicine used on the skin to treat people
with Stage 1A and 1B mycosis
fungoides-type cutaneous T-cell lymphoma who have received previous
skin treatment. It is not known if
VALCHLOR is safe and effective in children.
Who should not use VALCHLOR?
Do not use VALCHLOR if you are severely allergic to mechlorethamine.
Tell your healthcare provider if
you have had an allergic reaction to mechlorethamine.
What should I tell my healthcare provider before using VALCHLOR?
Before using VALCHLOR, tell your healthcare provider about all of your
medical conditions, including
if you:
•
are pregnant or plan to become pregnant. VALCHLOR can harm your unborn
baby. You should
not become pregnant while using VALCHLOR. Tell your healthcare
provider right away if you
become pregnant while using VALCHLOR.
•
are breastfeeding or plan to breastfeed. It is not known if VALCHLOR
passes into your breast
milk. You and your healthcare provider should decide if you will use
VALCHLOR or breastfee

Ürün özellikleri

VALCHLOR- MECHLORETHAMINE HYDROCHLORIDE GEL
ACTELION PHARMACEUTICALS US, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALCHLOR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VALCHLOR.
VALCHLOR (MECHLORETHAMINE) GEL, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1949
INDICATIONS AND USAGE
VALCHLOR is an alkylating drug indicated for the topical treatment of
Stage IA and IB mycosis fungoides-type cutaneous
T-cell lymphoma in patients who have received prior skin-directed
therapy (1).
DOSAGE AND ADMINISTRATION
FOR TOPICAL DERMATOLOGICAL USE ONLY (2.1).
Apply a thin film once daily to affected areas of the skin (2.1, 2.2).
DOSAGE FORMS AND STRENGTHS
Gel: 0.016% w/w of mechlorethamine (equivalent to 0.02%
mechlorethamine HCl) in 60g tubes (3)
CONTRAINDICATIONS
Severe hypersensitivity to mechlorethamine (4)
WARNINGS AND PRECAUTIONS
Mucosal or eye injury: VALCHLOR exposure to mucous membranes,
especially of the eyes, can cause mucosal injury
which may be severe. Eye injury may lead to blindness. Immediately
irrigate for at least 15 minutes followed by
immediate medical consultation (5.1).
Secondary exposure to VALCHLOR: individuals other than the patient
must avoid skin contact with VALCHLOR (2.2,
5.2).
Dermatitis: Monitor patients for redness, swelling, inflammation,
itchiness, blisters, ulceration, and secondary skin
infections. Stop treatment or reduce dose frequency (2.1, 5.3).
Non-melanoma skin cancer: Monitor patients during and after treatment
(5.4).
Embryo-fetal toxicity: Can cause fetal harm. Advise women of potential
hazard to a fetus (5.5, 8.1).
Flammable gel: VALCHLOR is an alcohol-based gel. Avoid fire, flame,
and smoking until the gel has dried (2.2, 5.6).
ADVERSE REACTIONS
The most common adverse reactions (≥5%) are dermatitis, pruritus,
bacterial skin infection, skin ulceration or blistering,
and hyperpigmentation (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ACTELION
PHARMACEUTICALS US, INC., AT 1-855-4-
VALCHLOR