New Drug Approvals From 2010

Even though a number of drugs were approved for use in 2010, they are just now hitting pharmacy shelves (and it will likely be a little longer before doctors start to write for them and insurances start to cover them). Knowing as much as you can about these drugs, their storage and related information will ensure that you can help your pharmacist keep your patients safe. Click on the name of the drug for full prescribing information as provided by the manufacturer.

Pradaxa (Dabigatran Etexilate Mesylate)
by Boehringer Ingelheim Pharmaceticals, Inc.

Use: Reduce risk of stroke and embolism in patients with fibrillation
Normal Dosage: 150mg twice daily; 75mg twice daily with lower kidney function
Pregnancy Category: C - No controlled studies
Contraindications: Active, pathological bleeding
Side Effects: Indigestion, stomach pain,
Availability: Capsules: 75mg, 150mg
Special Storage Requirements: Pradaxa should be kept in the original stock bottle and only opened to remove a capsule for dosage. It should not be removed from the stock bottle to be placed in pill planners and all capsules should be taken within 30 days of the package being opened. Pharmacy staff should not break the stock bottle for dispensing. More information can be found here here. Bottles now come with a tamper-evident closure tape. Patients should refuse a bottle if the tape is broken and pharmacies should contact their wholesaler if they receive a bottle with broken tape.
Manufacturer Discount Coupons: By joining the Pradaxa Housecall Support Program patients can receive a coupon card for a free month's supply of Pradaxa.

Ampyra (Dalfampridine)
by Acorda Therapeutics, Inc.

Use: To improve walking in patients with MS
Normal Dosage: 10mg twice daily
Pregnancy Category: C - No adequate studies
Contraindications: History of seizures, certain kidney problems
Side Effects: Urinary tract infection, insomnia, dizziness, headache, nausea, backpain, MS relapse, constipation, upset stomach, paresthesia
Availability: Extended Release Tablets: 10mg
Special Storage Requirements: Controlled room temperature
Manufacturer Discount Coupons: No manufacturer coupons exist to date, but patients may be elligible for copay assistance by contacting Ampyra Patient Support Services toll-free at 1-888-881-1918 Monday through Friday, from 8 am to 8 pm ET.

Natazia (Estradiol Valerate and E.Valerate/Dienogest)
by Bayer Healthcare Pharmaceuticals

Use: Pregnancy prevention in sexually active females
Normal Dosage: Once daily
Pregnancy Category: X - Damage to fetus extremely likely
Contraindications: Smoking, history of clotting, estrogen or progestin-sensitive cancer, liver disease, age over 35 years
Side Effects: Spotting, Nausea, Headaches,
Availability: 28-day dose pack
Special Storage Requirements: Controlled room temperature
Manufacturer Discount Coupons: There is no coupon for Natazia specifically, but there is a Bayer Savings Card. Natazia is an elligible Bayer medication.

Zortress (Evrolimus)
by Novartis Pharmaceuticals Corp

Use: Prophylaxis of organ rejection in patients considered a low-moderate risk for rejection after kidney transplant
Normal Dosage: 0.75mg twice daily
Pregnancy Category: C - No adequate studies, animal studies show evidence of fetal harm
Contraindications: Sensitivity to evrolimus or sirolimus, use of strong inducers and inhibitors of CYP34A enzymes (including grapefruit juice)
Side Effects: Delayed or impaired wound healing, hyperlipidemia, protienuria, renal allograft thrombosis, angioedema
Availability: Tablets: 0.25mg, 0.5mg, 0.75mg
Special Storage Requirements: Controlled room temperature
Manufacturer Discount Coupons: A thirty-day free trial of Zortress is available, and Zortress copay cards are being made available to doctors and pharmacies through Novartis.

Victoza (Liraglutide rDNA Injection)
by Novo Nordisk

Use: In combination with diet and exercise to control blood glucose in patients with type II diabetes
Normal Dosage: Varies
Pregnancy Category: C - No adequate studies; teratogenic in rats
Contraindications: Type I diabetes, children, diabetic ketoacidosis, history of thyroid cancers
Side Effects: Thyroid tumors or cancers, headache, nausea, diarrhea, antibody formation
Availability: Prefilled pens: 6mg/3ml
Special Storage Requirements: Refrigerated
Manufacturer Discount Coupons: A Victoza Savings Card is available. It will pay up to $25 of the patient's copay each month. Some insurance companies automatically bill to the voucher program.

Lastacaft (Alcaftadine)
by Vistakon Pharmaceuticals

Use: Prevention of itching from allergic conjunctivitis
Normal Dosage: One drop in each eye daily
Pregnancy Category: B - Lab tests show no fetal harm
Contraindications: Contact lens-related irritation
Side Effects: Eye irritation, burning or stinging, eye redness, eye pruritus
Availability: 0.25% solution, 3ml and 5ml bottles
Special Storage Requirements: Controlled Room Temperature
Manufacturer Discount Coupons: Lastacaft doesn't offer any immediate copay savings, but there is a mail in rebate which will reduce the final out of pocket expenses to no more than $24

Gilenya (Fingolimod)
by Novartis Pharmaceuticals, Corp

Use: To delay clinical complications of MS
Normal Dosage: 0.5mg daily
Pregnancy Category: C - No adequate studies, but has demonstrated fetal harm in rats
Contraindications: Use of antiarrhythmic drugs, CYP34A enzyme inhibitors, live vaccines
Side Effects: Headache, influenza, diarrhea, back pain, liver enzyme eleation, cough, increased risk of infection, macular edema
Availability: Capusles: 0.5mg
Special Storage Requirements: Controlled Room Temperature
Manufacturer Discount Coupons: No coupon is available at this time.

Latuda (Lurasidone HCl)
by Sunovion Pharmaceuticals, Corp

Use: Treatment of schizophrenia
Normal Dosage: 40-80mg daily with food
Pregnancy Category: B - safe in lab test of rodents, but no controlled studies in pregnant women
Contraindications: Dementia-related psychosis, Strong CYP34A inhibitors
Side Effects: Sleepiness, restlessness, upset stomach, muscle stiffness, agitation, increased suicide risk
Availability: Tablets: 40mg, 80mg
Special Storage Requirements: Controlled Room Temperature
Manufacturer Discount Coupons: There is no specific coupon for Latuda, but Sunovion has a Sunovion Support assistance program.

ella (Ulipristal Acetate)
by Watson Pharmaceticals, Inc

Use: Emergency contraception in the event of known or suspected contraceptive failure or unprotected sex
Normal Dosage: One tablet within 5 days of intercourse
Pregnancy Category: X - Known fetal harm
Contraindications: pregnancy, not to be used as a regular contraceptive
Side Effects: Headaches, nausea, abdominal pain, dysmenorrhea, fatigue, dizziness
Availability: Tablet: 30mg
Special Storage Requirements: Controlled Room Temperature
Manufacturer Discount Coupons: No coupons available at this time

Resources: 
Mancano, Michael. "New Drugs of 2010: Part 1." Pharmacy Times. Pharmacy Times, 18 Jan 2011. Web. 31 May 2011. <https://secure.pharmacytimes.com/lessons/201101-02.asp>.

Mancano, Michael. "New Drugs of 2010: Part 2." Pharmacy Times. Pharmacy Times, 11 Feb 2011. Web. 31 May 2011. <https://secure.pharmacytimes.com/lessons/201102-02.asp>.

Appropriate prescribing information for each medication