Special Procedure Medications
Each of these drugs requires a special procedure in order to dispense.
Whenever there is a new patient coming in with one of these
medications, be aware that action needs to be taken ASAP. Some
require the physician and patient to be registered in a monitoring
program. Some cannot be dispensed by a pharmacy.
Accutane (isotretinoin)
 Used for treatment of severe acne that has not been helped by other treatments.
 Patient, physician and pharmacy must be registered with ipledge due to the teratogenic
risk. Dispense a maximum of a one month supply, with no refills and must be dispensed
within 7 days of date on yellow qualification sticker. The prescription must have this
yellow Accutane Qualification Sticker verifying that the patient and physician have taken
necessary precautions (two negative pregnancy tests before each written prescription, two
forms of contraception, etc)
 Contact: www.ipledgeprogram.com or 1-866495-0654
Ampyra (dalfampridine)
 Indicated as a treatment to improve walking in patients with multiple sclerosis (MS). This
was demonstrated by an increase in walking speed.
 Physician and patient must complete the enrollment form. The physician’s office faxes
the completed enrollment form to Ampyra Patient Support Services. Ampyra Patient
Support Services confirms the patient’s insurance and eligibility for co-pay mitigation
and forwards the prescription to a specialty pharmacy. The pharmacy will coordinate the
deliveries of Ampyra with the patient.
 Contact: Ampyra Patient Support Services at 1-888-881-1918 (phone) or 1-888-883-3053
(fax).
Avandia (Rosiglitazone)
 Indicated for the treatment of non-insulin dependent Type 2 diabetes mellitus.
 Includes rosiglitazone-containing medications: Avandamet, Avandaryl.
 Prescriber and patient must enroll in a special program. Dispensing of these medications
will be limited to mail order through ONLY 3 specialty pharmacies: Medco, Accredo
Wholesale and McKesson-Walgreens.
 Physician and patient must be registered in the REMS program. Enrollment forms are
available online at: https://www.avandia.com/
 Contact: Sanofi-Aventis at 1-800-AVANDIA (1-800-282-6342).
Caprelsa (Vandetanib)
 a kinase inhibitor, is for the treatment of symptomatic or progressive medullary thyroid
cancer in patients with unresectable locally advanced or metastatic disease.
 Use of CAPRELSA in patients with indolent, asymptomatic or slowly progressing
disease should be carefully considered because of the treatment related risks of
CAPRELSA.
 To prescribe CAPRELSA® (vandetanib) Tablets, you must enroll in the CAPRELSA
REMS Program and complete the prescriber training program. AstraZeneca will
regularly evaluate compliance and reserves the right to contact you from time to time as
a requirement of the CAPRELSA REMS Program.
 Certification in the CAPRELSA REMS Program requires 3 steps: 1. Review the HCP
Education Pamphlet or HCP REMS Educational Slide Set
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and the CAPRELSA full Prescribing Information . Complete the prescriber training
program. Registration with biologics 1 800 4306
 Contact: www.caprelsarems.com 1877893 1510
Clozapine (Clozaril, Fazclo)
 Indicated for treatment of severely ill patients with schizophrenia who fail to respond to
standard drug therapy or who are at risk of re-experiencing suicidal behavior.
 Available to enrolled health care practitioners and pharmacies only. Can be dispensed
ONLY to registered patients with valid patient registration numbers, a WBC count and
ANC report within the requirements of the clozapine product labeling WITHIN 7 DAYS
OF DISPENSING, and a prescription from an enrolled health care practitioner. Patient
must be assigned to a treating health care practitioner and dispensing pharmacy.
 Contact : www.clozapineregistry.com, www.clozarilcare.com, www.fazacloregistry.com
Entereg (Alivmopan) ENTEREG is the first and only FDA-approved agent indicated to accelerate the time to
upper and lower gastrointestinal (GI) recovery following partial large or small bowel
resection surgery with primary anastomosis
 WARNING: FOR SHORT-TERM HOSPITAL USE ONLY ENTEREG is available only
for short-term (15 doses) use in hospitalized patients. Only hospitals that have registered
in and met all of the requirements for the ENTEREG Access Support & Education
(E.A.S.E.™) Program may use ENTEREG.
 Contact info: http://www.entereg.com/ To get Product Pharmacy must be registered
with REMS 1(800)278-0340
ExJade (deferasirox)
 Indicated for treatment of chronic iron overload due to blood transfusions.
 Physician must assist patient in enrolling in the EPASS system (Exjade Patient
Assistance and Support Services)
 EPASS ensures that prescriptions are distributed via national specialty pharmacies, which
review reimbursement benefits and organize delivery of EXJADE to a patient's home or
location of choice. In addition, the specialty pharmacy will:
o Call to confirm receipt of EXJADE and answer any questions
o Call to remind your patients to refill prescription
o EPASS Complete Care provides ONGOING patient SUPPORT
 Contact: 1-888-903-7277 (phone), 1-888-891-4924 (fax), or email at www.epassrx.com
Increlex (mecasermin)
 Liquid containing man-made IGF-1 used to treat children who are very short for their age
because they do not make enough IGF-1.
 Physician and patient must complete an SMN form (statement of medical necessity), with
supporting documentation and a copy of the patient’s insurance card. Patient must also
sign a “patient authorization to use/disclose health information” form.
 Distribution Program: The manufacturer established the TerciCare program to
facilitate the prescribing, dispensing, and reimbursement processes. Increlex is only
available through specialty pharmacies working with the manufacturer.
 Increlex is currently dispensed through 4 specialty pharmacies: Accredo, Caremark,
CuraScript, and PharmaCare
 Contact: 1-866-837-2422 option #3; or www.tercica.com
Iressa (gefitinib)
 Used for non-small cell lung cancer
 No new patients will be allowed to have access to IRESSA unless they are enrolled into a
clinical trial approved prior to June.17th, 2005. IRESSA will only be obtainable through
the IRRESA Access Program by approved patients.
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 After September 15, 2005 pharmacies should not fill any prescription for IRESSA. After
this date, please refer any patient with an IRESSA prescription to the IRESSA Access
Program for assistance. The toll free number is: 1-800-601-8933. Patients can also be
referred to AstraZeneca for assistance at 1-800-601-8933
 Pharmacies cannot enroll patients into the IRESSA Access Program due to the patient
and physician consent/certification forms that are required by the program.
Letairis® (ambrisentan)
 to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the
arteries of your lungs. LETAIRIS can improve your ability to exercise and it can help
slow down the worsening of your physical condition and symptoms.
 BOXED WARNING Because of the risk of birth defects
 LETAIRIS is available only through a restricted program called the
LETAIRIS Education and Access Program (LEAP). To receive LETAIRIS,
you must talk to your doctor, understand the benefits and risks of LETAIRIS,
and agree to all of the instructions in the LEAP program serious birth defects:
LETAIRIS can cause serious birth defects if taken during pregnancy. Women
must not be pregnant when they start taking LETAIRIS or become pregnant
during treatment.
 Contact: http://www.letairis.com/patients/default.asp : (650) 574-3000
Lotronex (alosetron)
 Indicated ONLY for women with severe irritable bowel syndrome whose main problem
is diarrhea and who did not get the relief needed from other treatments.
 Can be ordered by MedWorld
 Pharmacists need to:
o Dispense only prescriptions that have a Prescribing Program Sticker - never fill
telephone, facsimile, or computer-generated prescriptions; refills are permitted on
written prescriptions
o Dispense a Retail Pack for LOTRONEX, which includes Medication Guide,
Prescribing Information, Medicine, and Follow-Up Survey Form
o Encourage your patients who are prescribed LOTRONEX to enroll in Follow-Up
Survey
 Contact: 1-888-825-5249 or www.lotronex.com
LUMIZYME (alglucosidase alfa) –
 is used to treat a glycogen storage disorder called Pompe disease
 Lumizyme is only available through a restricted distribution program called the
Lumizyme ACE (Alglucosidase Alfa Control and Education) Program®. Before placing
an order, physicians and healthcare facilities must complete training and enroll in the
program. Prescribers must ensure that patients are enrolled in the program. Genzyme
cannot authorize Lumizyme for shipment until all involved parties meet all program
requirements, which must be re-verified for each shipment
 Contact 800-745-4447
Mifeprex (mifepristone)
 Indicated for termination of pregnancy in patients who are ≤49 days pregnant, dated from
the first day of their last menstrual period.
 Physician must enroll in program to order this medication. Physician and patient must
sign a Patient agreement form and physician must set up a follow-up visit at
approximately 14 days to confirm complete termination of pregnancy.
 Mifeprex will be supplied only to licensed physicians who sign and return a Prescriber’s
Agreement. Distribution of Mifeprex will be subject to specific requirements imposed by
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the distributor, including procedures for storage, dosage tracking, damaged product
returns and other matters.
 Mifeprex is sold directly to approved physicians and is NOT AVAILABLE IN
PHARMACIES
 Contact: 1-877-4-EARLY OPTION www.earlyoptionpill.com
Nexavar (sorafenib)
 Indicated for treatment of advanced renal cell carcinoma.
 Physician must enroll patient in the REACH program (resources for expert assistance and
care helpline). Physician and patient must sign declaration form and fax it to 1-866-6395181.
 After verifying the patient's insurance coverage, the REACH Program Counselor will
send their prescription to a specialty pharmacy provider (SPP). The SPP will fill their
prescription and arrange for delivery of Nexavar to them. Before each refill is due, they
will receive a call to arrange the next delivery.
 Nexavar will not be filled through retail pharmacies, but can be supplied through the
Omnicare ACS Special Pharmacy (1-855-488-2550), contact your Med World
Pharmacist to order or get more information
 For more information contact Onyx at 1-866-639-2827 or www.NEXAVAR.com
Propulsid (cisapride)
 Treatment of noturnal symptoms of gastroesophageal reflux disease (GERD); has
demonstrated effectiveness for gastroparesis, refractory constipation, and nonulcer
dyspepsia
 Withdrawn from the market due to fatal arrhythmias
 Avilable only through an investigational limited access program for specific conditions
(gastroparesis, severe chronic constipation, and feeding intolerance in neonates. Patients
must also meet the strict enrollment criteria.
 Institutions board review approval, completed FDA 1572 form and signed informed
consent .
 To get more information on enrolling the pharmacy and procedures involved visit
www.propulsid-lap.com or call 1-877-795-4247
Revlimid (lenalidomide)
 Indicated for myelodysplastic syndromes or multiple myeloma
 Revlimid can ONLY be prescribed by healthcare providers who are registered in the
RevAssist program, dispensed by a pharmacy that is registered in the RevAssist program,
and given to patients who are registered in the RevAssist program and who agree to do
everything required in the program.
 Can be ordered through Omnicare ACS Special Pharmacy (1-855-488-2550), contact
your Med World Pharmacist to order or get more information.
 For more information contact Celgene at 1-888-423-5436 or www.revlimid.com
Sabril (Vigabatrin)
 This is an anticonvulsant indicated for infantile spasms, refractory complex partial
seizures not controlled by conventional treatments.
 Only available through the Support, Help and Resources for Epilepsy (SHARE) program.
The physician and patient need to be registered with the program in order to prescribe
and dispense Sabril. This med can only be given to patients enrolled in and meet all
conditions of SHARE.
 All initial prescriptions for Sabril must go through the SHARE Call Center (1-888-45SHARE [1-888-457-4273]) and will then be fulfilled by a specialty pharmacy
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 Sabril is not available at retail pharmacies. Sabril is only available through 4 select
specialty pharmacies (Accredo, Curascript, Pharmacare, and Caremark) as of 2/24/10
 Forms available at http://www.lundbeckshare.com/pg512_important_steps.aspx .
Contact SHARE at 1-888-45-SHARE.
Soliris (Eculizumab) Soliris is indicated for the treatment of patients with paroxysmal nocturnal
hemoglobinuria (PNH) to reduce hemolysis. Atypical Hemolytic Uremic Syndrome
(aHUS) and for the treatment of patients with atypical hemolytic uremic syndrome
(aHUS) to inhibit complement-mediated thrombotic microangiopathy.
 Life-threatening and fatal meningococcal infections have occurred in patients
treated with Soliris, may become rapidly life-threatening or fatal if not
recognized and treated early. Comply with the most current Advisory
Committee on Immunization Practices (ACIP) recommendations for
meningococcal vaccination in patients with complement deficiencies
 Immunize patients with a meningococcal vaccine at least 2 weeks prior to
administering the first dose of Soliris, unless the risks of delaying therapy
outweigh the risks of infection. Monitor patients for early signs of
meningococcal infections, and evaluate immediately if infection is suspected.
Soliris is available only through a restricted program under a Risk Evaluation
and Mitigation Strategy (REMS).
 Soliris is available only through a restricted program under a Risk Evaluation and
Mitigation Strategy (REMS)
 Can be ordered through Omnicare ACS Special Pharmacy (1-855-488-2550), contact
your Med World Pharmacist to order or get more information.
 For more information contact the maker of Soliris at 1-888-SOLIRIS (1-888765-4747)
Sucraid (sacrosidase) oral solution is an enzyme replacement therapy for use in the treatment of Congenital
Sucrase-Isomaltase Deficiency (CSID) developed initially by Orphan Medical, Inc.
CSID is a condition where your body lacks the enzymes needed to properly break down
and absorb sucrose (table sugar) and isomaltase (a type of starch) from the intestines.
 It is important that licensed healthcare providers use the Sucraid® Patient Enrollment
Form for new patients on therapy to ensure initial patient access and an uninterrupted
supply of therapy as prescribed. Please complete the Sucraid® Patient Enrollment Form
online, then print, sign (both patient and physician signature is required), and fax to 1866-777-7097. You can also scan the completed form and email it to info@qolmed.com.
This form provides all of the information required by the exclusive specialty pharmacy
provider to arrange for patient access to Sucraid® Oral Solution.
 Can be stocked in pharmacy
 Contact: Phone: 1-866-469-3773 Fax: 772-365-3375 Email: info@qolmed.com
Suboxone, Subutex (buprenorphine)
 Used for maintenance and detoxification treatment in opioid addicted patients.
 Registration as Narcotic Treatment Program (NTP) is no longer required for
prescribing/dispensing drugs for maintenance and detox therapies. ONDCPRA modified
the restriction on the number of patients a physician is authorized to treat under the drug
Addiction Treatment Act of 2000 (DATA 2000)
 Contact: 866-BUP-CSAT (866-287-2728) or email at info@buprenorphine.samhsa.gov
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Thalomid (thalidomide)
 Indicated for treatment of patients with newly diagnosed multiple myeloma and for the
acute treatment of cutaneous manifestations of moderate to severe erythema nodosum
leprosum.
 Required Registration of Prescribers, Patients, and Pharmacies
o All prescribers, patients, and pharmacies are required to register in the S.T.E.P.S.®
program in order to prescribe, receive, or dispense Thalomid®.
o Physician registration requires a DEA# or Social Security Number as well as the
designation of a S.T.E.P.S.® coordinator for that prescriber (this may be the
prescriber). The registration form is faxed to the prescriber and when completed
faxed back to Celgene Corporation.
o A pharmacy registers by having a designated pharmacist complete a similar
registration form that is returned to Celgene.
 Authorization Validation
o After the risk group appropriate patient acknowledgement / informed consent
form has been completed and faxed to Celgene Corporation the patient is then
instructed to complete the patient phone survey while the prescriber completes the
physician phone survey.
o Upon completion of the survey, the physician obtains an authorization number
that is placed on the prescription which the patient then presents to the
pharmacist. WITHOUT THE AUTHORIZATION NUMBER, THALOMID®
CANNOT BE DISPENSED.
 Limiting Prescriptions to a 28-day Supply
o Thalomid® prescriptions are limited to a duration of 28-days to allow for
appropriate interval follow-up. Telephone prescriptions are not permitted. A
new prescription is required for further dispensing (i.e. automatic refills are not
permitted). To reflect the temporal restriction with regard to recent pregnancy
testing, Thalomid® prescriptions are required to be filled WITHIN SEVEN DAYS
of issue.
 Distribution of Thalomid® from Celgene to Registered Pharmacies
o Thalomid® is directly shipped from Celgene to registered pharmacies. This
allows Celgene to compare the amount of Thalomid® shipped to pharmacies with
the amount of Thalomid® that specific pharmacies have been authorized to
dispense.
 Can be ordered through Omnicare ACS Special Pharmacy (1-866-681-7131), contact
your Med World Pharmacist to order or get more information.
 For more information contact the makers of Thalomid at:1-888-423-5436
Tikosyn (dofetilide)
 Indicated for the maintenance of normal sinus rhythm in patients with atrial
fibrillation/flutter of greater than one week duration who have been converted to normal
sinus rhythm. Reserved for highly symptomatic patients.
 Physician must sign a TIKOSYN education program enrollment form to ensure that only
prescribers who received appropriate education on treatment initiation and dosing
guidelines can initiate TIKOSYN in a hospital setting and/or write prescriptions for this
drug.
 T.I.P.S.™ stands for TIKOSYN In Pharmacy System. The T.I.P.S. program is designed
to allow retail pharmacies to stock and dispense TIKOSYN once they have been enrolled.
A retail pharmacy can enroll in the T.I.P.S. program by Completing and submitting the
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online T.I.P.S. Enrollment Form and ordering a T.I.P.S. Information Kit. Call 1-877TIKOSYN (845-6796) to request a T.I.P.S. Enrollment and Information Kit.
 MEDWORLD IS ENROLLED IN THE T.I.P.S. PROGRAM. Therefore, the pharmacy
acknowledges receipt of the T.I.P.S. program materials and that the appropriate staff in
the pharmacy are aware that for each outpatient prescription for TIKOSYN:
o The pharmacist will verify that a prescriber has participated in the TIKOSYN
Education Distribution Program and is confirmed in the TIKOSYN database
before dispensing by checking the database via the Interactive Voice Response
(IVR) telephone number, 1-800-788-7353, or the Web site,
http://www.tikosynlist.com/.
o The pharmacist will stamp each prescription for distribution with the T.I.P.S.™
stamp, verifying that the prescriber is a confirmed participant in the TIKOSYN
Education Distribution Program. The pharmacist will then initial and date the
stamped prescription in the appropriate areas. (stamp is kept in the IV department)
o A copy of the above information is posted or otherwise made available to
pharmacy staff to ensure that the staff understands these special conditions for use
of TIKOSYN.
 The PharmaCare Specialty Pharmacy mail-order program will continue to be available to
patients who prefer to receive their medication through PharmaCare. Upon patient
discharge, PharmaCare requires the pharmacy enrollment form be completed and faxed
along with the prescription, to PharmaCare Specialty Pharmacy.
 Contact: 1-877-TIKOSYN
Tracleer (bosentan)
 Indicated for treatment of pulmonary arterial hypertension
 Because of the risks associated with treatment, the use of Tracleer requires participation
in the Tracleer Access Program (T.A.P.), a restricted distribution program.
 TRACLEER IS NOT AVAILABLE IN A RETAIL PHARMACY.
 Contact: 1-866-228-3546
Tysabri (natalizumab)
 Indicated for patients with relapsing forms of MS and is available as a 1hr IV slow drip
infusion
 TYSABRI is available only under a special restricted distribution program called the
TOUCH® Prescribing Program. Under the TOUCH® Prescribing Program, only
prescribers, infusion centers, and pharmacies associated with infusion centers registered
with the program are able to prescribe, distribute, or infuse the product. Currently, 11
pharmacies nationally participate.
 For prescribers and patients, the TOUCH® Prescribing Program has two components:
MS TOUCH® (for patients with multiple sclerosis) and CD TOUCH® (for patients with
Crohn's disease). TYSABRI must be administered only to patients who are enrolled in
and meet all the conditions of the MS or CD TOUCH® Prescribing Program.
 Contact the TOUCH® Prescribing Program at 1-800-456-2255
 Contact: www.TYSABRI.com
Ventavis (Iloprost)
 Ventavis is used for severe pulmonary arterial hypertension (PAH).
 Some of the side effects include feeling dizzy, lightheaded, and faint. The most common
side effects of Ventavis include red face (flushing), increased cough, low blood pressure,
headaches, nausea, spasm of your jaw muscles that makes it hard to open your mouth,
and fainting.
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 This is distributed through a specialty pharmacy. It is taken with a special nebulizer
device-the I-neb AAD.
 For more information 1-866-228-3546 (1-866-ACTELION)
Vivitrol (naltrexone)
 Indicated for the treatment of alcohol dependence in patients who are able to abstain from
alcohol in an outpatient setting prior to initiation of treatment with Vivitrol.
 Physicians, patients and providers must complete the VIP program enrollment form and
submit it via fax or phone.
 AVAILABLE ONLY THROUGH 4 SPECIALTY PHARMACIES HANDLING
VIVITROL IM (Caremark, Coram, Pharmacare, and Curascript)
 Contact: 1-800-848-4876 (phone) or 1-877-329-8484 (fax)
Xenazine (tetrabenzine)
 Indicated for the treatment of chorea (brief, repetitive, jerky, or dancelike uncontrolled
movements caused by muscle contractions) associated with Huntington’s disease.
 Xenazine requires a Risk Evaluation and Mitigation Strategy (REMS) to ensure the
benefits outweigh the risks. Xenazine has a black box warning for depression and
suicidality.
 Xenazine is AVAILABLE ONLY THROUGH SPECIALTY PHARMACIES because of
factors that relate to its orphan drug status and the need to provide appropriate education
on the Risk Evaluation & Mitigation Strategy (REMS) program.
 Physician and patient fill out Xenazine Treatment Form and fax back to Xenazine
Information Center. The medication is housed at 3 specialty pharmacies nationally and is
either mailed directly to the patient or to the prescriber’s office, as requested on the
treatment form. Monitoring and follow up is done by physician and adverse effects
reported to the center.
 Can be ordered through Omnicare ACS Special Pharmacy (1-855-488-2550), contact
your Med World Pharmacist to order or get more information.
 For more information contact the makers at: 1 888 882 6013,
www.xenazineusa.com/healthcareprofessionals/prescribingxenazine/
Xyrem (sodium oxybate)
 Indicated for treatment of patients with narcolepsy who experience episodes of cataplexy,
weak or paralyzed muscles.
 XYREM is a controlled substance (CIII). The active ingredient of XYREM is a form of
GHB and has been a target for persons who abuse drugs and should be regulated as such.
 Patient and physician must be enrolled in Xyrem Risk Management Program.
 Medication is housed in a single centrallized pharmacy rather than a traditional retail
pharmacy. Physician must see patient at least every 3 months.
 ALL XYREM PRESCRIPTIONS ARE FILLED BY A CENTRAL, MAIL ORDER
PHARMACY.
 Contact: 1-866-XYREM-88
Zyprexa Relprevv
 This is a long acting atypical antipsychotic injectable medication.
 This med is restricted because of post injection delirium sedation syndrome (PDSS)
which is severe drowsiness (including coma) and/or confusion and disorientation after
each injection and must be observed at the doctor’s office or clinic for at least 3 hours
after the injection is given.
 Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at
an increased risk of death. ZYPREXA RELPREVV is not approved for the treatment of
patients with dementia-related psychosis.
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 Only prescribers and pharmacies registered with the program and prescribe and dispense
this med.
 Med World pharmacy is not registered in the program.
Zytiga (abiraterone)
 Use in combination with prednisone for patient with metastatic castration-resistant
prostate cancer (CRPC) who have received prior chemotherapy containing docetaxel.
 Hypertension, hypokalemia, and fluid retention due to mineralocorticoid excess,
adrenocortical insufficiency, and hepatotoxicity.
 Can be ordered through Omnicare ACS Special Pharmacy (1-855-488-2550), contact
your Med World Pharmacist to order or get more information.
 For the Janssen Support line contact 1-855 ZYTIGA
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