Following is a P and T Committee update (from the Oct 28th meeting).  Starting date for specific programs is Nov. 3rd, 2014, unless otherwise noted.  This information should soon be available in the formulary notebooks, the formulary website, and Formulary One-Source.  Please let me know if you have any questions or comments.  Don’t forget to check the “New Drug Monitoring Spotlight” section of the website, which provides important monitoring information about newly approved drugs.  Also, attached is the updated version of the “Not Stocked, Not Ordered” drug list with the new additions highlighted in red.

Below is the memo with links to the drug monographs, protocols, and formulary documents. Click to access the full P&T packet for this month, or here to access the P&T packet archive.

belinostat (Beleodaq) – This is a new intravenous drug approved to treat relapsed or refractory peripheral T-cell lymphoma (PTCL), the dose is based on body surface area, and it is administered as an intravenous infusion on days 1 – 5 of a 21 day cycle. This drug is associated with various adverse effects and drug interactions, and is considered genotoxic, embryotoxic, and a hazardous and cytotoxic drug by OSHA.  An average dose over a 3 week period would cost approximately $20,000 - $30,000.  Rare use is expected.  It was classified as formulary status, limited to outpatient use. 

empagliflozin (Jardiance) – This drug is the third agent approved in the brand new pharmacological drug class of sodium-glucose co-transporter 2 inhibitors, and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. The 2 similar agents on the market are canagliflozin (Invokana) and dapagliflozin (Farxiga).  The initial dose is 10 mg once daily in the am, and may be increased to 25 mg once daily if needed.   The drug should not be given if GFR is estimated to be < 45 ml/min/1.73 sq.m.   This drug is associated with increased urination, dehydration, hypotension, hypoglycemia, and genital mycotic infections.  It was classified as a formulary agent.

dimethyl fumarate (Tecfidera) – This drug is approved for first-line treatment of relapsing forms of multiple scelrosis and is available as a delayed release oral capsule. The initial dose is 120 mg bid for 7 days, then increased to the general maintenance dose of 240 mg bid.   The daily cost for either the 120 mg or 240 mg  capsule, dosed bid, is $143.  This drug was originally classified as a formulary agent, but now it is only available through specialty pharmacies and sent directly to the patient, and the hospital cannot order this medication.  The formulary classification was updated to be non-formulary, not stocked.  Low use expected.

topiramate (Qudexy XR) Extended Release – This new dosage form is indicated for initial monotherapy or as adjunctive therapy for partial onset seizures (POS) or primary generalized tonic-clonic seizures (PGTCS), and as an adjunctive therapy for seizures related to Lennox-Gastaut Syndrome (LGS). The initial dose is 25  - 50 mg once daily, and the dose is titrated up slowly to reach a general maintenance dose of 200 – 400 mg once daily, depending on indication.   There is specific weight based dosing for children 2 years or older.  Total drug exposure and the ADR profile are similar to generic topiramate dosed bid, but the cost is much more expensive.  Qudexy XR was classified as non-formulary, not stocked, and will be interchanged to generic topiramate with the same total daily dose, but dosed bid.  The patient may use their own supply of Qudexy XR if necessary in the hospital.

topiramate (Trokendi XR) Extended Release – This new dosage form is also indicated for monotherapy or adjunctive therapy for POS and PGTCS, and for adjunctive therapy for seizures related to LGS. The starting dose in adults is 50 mg once daily, and the dose is titrated up slowly to a usual dose of 400 mg once daily.  There is also specific dosing for children 6 years and under.    Total drug exposure and ADR occurrences are approximately the same as immediate release topirimate, but Trokendi XR is much more expensive.  Trokendi XR was classified as non-formulary, not stocked, and will be interchanged to generic topiramate with the same total daily dose, but dosed bid.  The patient may use their own supply of Trokendi XR if necessary in the hospital.

OXcarbazepine (Oxtellar XR) Extended Release – This new dosage form is indicated for adjunctive therapy for POS in adults and children 6 yrs and older. For adults, the initial dose is 600 mg once daily, and the dose is gradually titrated up to the 1200 – 2400 mg range per day.  There is specific pediatric dosage guidelines also.   A 1200 mg dose of Oxtellar XR once daily gives 19% lower overall drug exposure and a 16% reduction in Cmax compared to the immediate release tablet 1200 mg daily, divided in bid dosing.   There are no direct comparisons of ADR occurrences between the 2 dosage forms.  Oxtellar XR was classified as a formulary agent, and will be interchanged to immediate release oxcarbazepine in the same total daily dose, but dosed bid, unless “no substitution” is written with the original drug order.  For pediatric patients, the physician should be contacted to determine if the patient could receive the immediate release preparation during hospitalization.  If needed, the patient may use their own supply of Oxtellar XR. 

methlorethamine (Valchlor) Gel – This new topical product is an alkylating agent indicated for the treatment of stage 1A and 1B mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. A thin film is applied once daily to the affected area.  Precautions include mucosal or eye injury, secondary exposure, dermatitis, skin cancer, and embryo-toxicity.  Special precautions should be taken when applying and storing the product.  The cost is $3,480 per 60 gram tube and this drug is sent directly to the patient from a specialty pharmacy.  The drug was classified as non-formulary, not stocked.  Use should be deferred to the outpatient setting if possible (pharmacist should contact physician to determine if drug can be held during hospitalization).  If judged necessary that patient should use Valchlor in the hospital, they must use their own supply; and special precautions  with handling and administration as instructed in the package insert should be taken.   There will be a computer prompt for attention to specific administration procedures.

pseudoephedrine (Zephrex–D) – This OTC product is pseudoephedrine immediate release 30 mg tablet in a abuse-deterrent form, it is dosed q 4 – 6 hrs, and it is higher cost than the regular tablet. It was classified as non-formulary, not stocked, and the regular generic pseudoephedrine tablet should be used for inpatients and hospital outpatients.

oxybutynin (Oxytrol for Women Patch) – This OTC product is the same as Oxytrol Patch, but is over the counter and much less expensive, with OTC intended for women only so usage in men will be screened through the prescription process for BPH before using this patch. The dose for either patch is one 3.9 mg /day patch applied every 3 – 4 days.  Oxytrol for Women patch was classified as formulary, and interchanged to Gelnique gel, 1 packet once daily, but  available if “no substitution” is written with original order.  Oxytrol patch was classified as non-formulary, not stocked, and should be interchanged to Gelnique gel also, but if Oxytrol patch is written “no substitution”, then Oxytrol for Women should be dispensed for both women and men, as it is much less expensive than Oxytrol and the patch contains no statement on it about for use in women only.       

Phenylephrine / Ibuprofen Combination – This OTC combination is known as Advil Congestion Relief and is available generically. It is used to treat allergy and cold symptoms, contains phenylephrine 10 mg and ibuprofen 200 mg, and dosed q 4 hrs as needed.  The product is not recommended for use in children.  The combination tablet was classified as non-formulary, not stocked, and the separate tablets should be dispensed for the combination product.

alteplase (TPA) and dornase alpha for intrapleural use – This protocol addresses use of these agents in pleural effusion cases, and includes mainly dosage, administration, and monitoring issues. The 2 drugs must be prepared in separate syringes.  The protocol was approved for use. 

ADRs – There were 136 ADRs reported in July/August, with 5% being classified as preventable.  Drugs associated with the most ADR reports included vancomycin, levofloxacin, morphine, and insulin.  Insulin was involved in the majority of the preventable reactions, with excessive dosing being the main cause.