New medicines
Gardasil
Composition: Human papillomavirus (HPV) vaccine, types 6,11, 16 and
18 (recombinant, adsorbed).
Presentation: Suspension for injection.
Class: Viral vaccine.
Indication: Prevention of high-grade cervical dysplasia, cervical carcinoma,
high-grade vulvar dysplastic lesions and external genital warts caused
by HPV types 6, 11, 16 and 18. The indication is based on demonstration
of efficacy of Gardasil in women 16–26 years old and of immunogenicity
in 9–15 year olds.
Dosage: The primary vaccination series consists of three separate 0.5ml
doses at zero, two and six months.
Contraindications: Administration should be postponed in subjects suffering
from an acute severe febrile illness, although the presence of a minor
infection is not a contraindication for immunisation.
Precautions: Appropriate precautions against sexually transmitted diseases
should continue to be used. Gardisil is not indicated for the treatment
of cervical cancer, high-grade cervical, vulvar and vaginal dysplastic
lesions or genital warts. It is also not intended to prevent progression
of other established HPV-related lesions. Individuals with impaired immune
responsiveness may not respond to the vaccine. Gardisil should be given
with caution to those with thrombocytopaenia or any coagulation disorder
because they may experience bleeding following an intramuscular administration.
Side effects: Very common (>=1/10) pyrexia and injection site erythema,
pain and swelling; common (>=1/100, <1/10) bleeding and pruritus
at the injection site.
Legal category: POM.
Net price: 1 x pre-filled syringe, £80.50.
Contact details: Sanofi Pasteur MSD, Mallards Reach, Bridge Avenue, Maidenhead,
Berkshire SL6 1QP (tel 01628 785291).
Savene
Composition: Dexrazoxane.
Presentation: Powder for concentrate 20mg/ml and diluent for solution
for infusion.
Class: Detoxifying agent for antineoplastic agents.
Indication: Treatment of anthracycline extravasation.
Dosage: Savene should be administered once daily for three consecutive
days, as an intravenous infusion over 1–2 hours into a large vein
in an area other than that affected by extravasation. The recommended
doses is 1,000mg/m2 on days 1 and 2, and 500mg/m2 on
day 3. For patients with a body surface area of more than 2m2 a single
dose should not exceed 2,000mg. The first infusion should be started
as soon as possible and
within six hours of the extravasation incident, although cooling measures
should be removed from the affected area at least 15 minutes before Savene
administration to allow sufficient blood flow.
Contraindications: Savene is contraindicated for women of childbearing
potential not using contraceptive measures, for use during lactation,
and for use concomitantly with yellow fever vaccine.
Precautions: If there is suspicion of extravasation by vesicant compounds
other than anthracyclines through the same IV access (for example, vincristine,
mitomycin and vinorelbine), Savene would not be effective against the
reaction from these compounds. Because the cytotoxic potential of Savene
will be additive in patients undergoing cytotoxic chemotherapy, haematological
monitoring should be undertaken regularly. Liver function tests should
be performed before each administration of Savene in patients with known
liver function disorders. Patients with initial impaired renal function
may experience a decreased rate of elimination of Savene and should be
monitored for signs of haematological toxicity. Savene is not recommended
in patients with impaired hepatic or renal functions. Men treated with
Savene are advised not to father a child during and up to three months
after treatment and women of childbearing potential must use contraceptive
measures during treatment. Savene should not be used in combination with
live attenuated vaccines, with phenytoin, and with dimethylsulfoxide.
Side effects: Very common (>=1/10) nausea, injection
site pain, postoperative infection; common (>1/100, <1/10) vomiting,
diarrhoea, stomatitis, dry mouth, pyrexia, injection site reactions,
fatigue, peripheral oedema,
somnolence, infection, neutropenic infection, wound complication, reduced
weight, decreased appetite, myalgia, dizziness, sensory loss, syncope,
tremor, vaginal haemorrhage, dyspnoea, pneumonia, alopecia, pruritus,
phlebitis, limb venous thrombosis, superficial thrombophlebitis.
Legal category: POM.
Net price: 10 x 500mg vials (with 3 diluent infusion bags), £6,750.
Contact details: TopoTarget A/S, Fruebjergvej 3, 2100 Copenhagen, Denmark
(tel +45 3917 8392).
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