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More. . . Copyright © 2010 by Therapeutic Research Center

Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.pharmacistsletter.com ~ www.prescribersletter.com

Detail-Document #261213 −This Detail-Document accompanies the related article published in− PHARMACIST’S LETTER / PRESCRIBER’S LETTER

December 2010 ~ Volume 26 ~ Number 261213

Dose Conversions for Epoetin and Darbepoetin

Background Darbepoetin alfa (Aranesp) was approved in

2001 for the treatment of anemia associated with chronic kidney disease or chemotherapy in non-myeloid malignancies.1 It’s an alternative to epoetin alfa (Epogen, Procrit) and is attractive because of the need for less frequent dosing. The half-life of darbepoetin alfa is about three times as long as the half-life of epoetin alfa.1 A recent shortage of some strengths of epoetin alfa due to a recall has prompted pharmacists to ask the best way to convert patients to darbepoetin alfa. This document reviews information on converting from epoetin alfa to darbepoetin alfa.

Converting Epoetin to Darbepoetin

The equimolar dose of 200 units of epoetin alfa is 1 mcg of darbepoetin alfa. These amounts of drug contain the same peptide mass.2

However, using the 200:1 ratio for dose conversion from epoetin alfa to darbepoetin alfa has resulted in the need for dose reduction of darbepoetin alfa in a number of studies. At equimolar doses, darbepoetin alfa is actually more potent than epoetin alfa. In fact, a conversion factor between 250:1 and 350:1 or higher appears to be more accurate. This has been shown in patients with chronic kidney disease (CKD) getting hemodialysis2-6 and in CKD patients not getting hemodialysis.2,7 It seems to be especially true for higher doses of epoetin alfa, such as those exceeding 5,000 units weekly.5 The same is true when longer intervals between doses are used. The potency of darbepoetin alfa is disproportionately higher than epoetin alfa as dosing intervals of epoetin alfa increase.2,3

These facts are reflected in the U.S. product labeling for darbepoetin alfa, which contains a table with dose conversions for epoetin alfa to darbepoetin alfa in patients with CKD. Conversions are based on ranges of doses of epoetin alfa. For example, adult patients who are getting 5,000 to 10,999 units of epoetin alfa per

week would be converted to 25 mcg per week of darbepoetin alfa. The extremes of these conversions go from a low end of about 1 mcg of darbepoetin alfa for every 900 units of epoetin alfa to up to a high end of about 1 mcg of darbepoetin alfa for every 200 units of epoetin alfa. However, the mean dose ratio generally increases as the dose of epoetin alfa increases, accounting somewhat for the disproportionate potencies.1

In light of safety issues with erythropoietins in patients receiving myelosuppressive chemotherapy, the newest guidelines for the use of these drugs in such individuals recommend sticking with FDA-approved doses.8

Converting Darbepoetin to Epoetin

Clinicians point out that another quandary is converting patients from darbepoetin alfa to epoetin alfa. This was necessary in some practice settings when some lots of the lower strengths of epoetin alfa were recalled in late 2010, causing a temporary shortage of some of the products. Patients were given darbepoetin alfa, and in some cases need to be converted back to epoetin alfa once product became available again. In addition, some hospitals may not prefer to use darbepoetin alfa for inpatients because of reimbursement issues, and may want to switch inpatients to epoetin alfa.

A reasonable approach to this would be to convert back to the patient’s original dose of epoetin alfa that the conversion to darbepoetin alfa was based on. However, if the patient was not originally started on epoetin alfa, this would not be an option. Another approach that has been suggested is to choose a conversion ratio based on your patient population, convert the darbepoetin alfa dose to epoetin alfa, and then divide the dose of epoetin alfa according to the preferred dosing interval (e.g., three times weekly, etc). For example, one study showed that a conversion ratio of 250 to 350 units of epoetin alfa to 1 mcg of

(Detail-Document #261213: Page 2 of 3)



darbepoetin alfa is appropriate for hemodialysis patients getting 5,000 units or more of epoetin alfa weekly.5 Results from another study showed a mean conversion ratio of 330 units of epoetin alfa to 1 mcg of darbepoetin alfa for nondialyzed chronic kidney disease patients.7 Another approach might be to convert from darbepoetin alfa to the dose of epoetin alfa approved for the patient’s indication.8

Studies have shown a large interpatient variability in the doses of darbepoetin alfa upon conversion from epoetin alfa. This places emphasis on the fact that individualization of therapy is necessary, based on each patient’s hemoglobin response.2

Conclusion

Using a dose conversion for epoetin alfa to darbepoetin alfa based on equivalent peptide mass, or 200 units of epoetin alfa to 1 mcg of darbepoetin alfa, is likely to overestimate darbepoetin alfa dose, especially at higher doses of epoetin alfa or when longer dosing intervals of epoetin alfa are being used [Evidence level B; nonrandomized clinical trial].5-7 The information on dose conversion in the Aranesp product labeling (http://www.aranesp.com/pdf/aranesp_pi. pdf) is a starting point for patients with CKD. When converting from epoetin alfa to darbepoetin alfa in these patients, use the same route of administration. Determine the total weekly dose of epoetin alfa to determine the dose of darbepoetin alfa. Give darbepoetin alfa once weekly if the patient was getting epoetin alfa two or three times weekly. Give darbepoetin alfa every two weeks if epoetin alfa was being given once weekly. Titrate the dose of darbepoetin alfa to maintain hemoglobin in the 10 to 12 g/dL range.1,2 Stick with FDA-approved doses of these drugs for patients getting myelosuppressive chemotherapy.8

For more information on the safety of erythropoietins and the new REMS, see our chart, Drugs with REMS and Other Special Dispensing/Prescribing Requirements.

Users of this document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national

organizations. Information and Internet links in this article were current as of the date of publication.

Levels of Evidence In accordance with the trend towards Evidence-Based Medicine, we are citing the LEVEL OF EVIDENCE for the statements we publish.

Level Definition A High-quality randomized controlled trial (RCT)

High-quality meta-analysis (quantitative systematic review)

B Nonrandomized clinical trial Nonquantitative systematic review Lower quality RCT Clinical cohort study Case-control study Historical control Epidemiologic study

C Consensus Expert opinion

D Anecdotal evidence In vitro or animal study

Adapted from Siwek J, et al. How to write an evidence-based clinical review article. Am Fam Physician 2002;65:251-8. Project Leader in preparation of this Detail-Document: Stacy A. Hester, R.Ph., BCPS, Assistant Editor References 1. Product information for Aranesp. Thousand Oaks,

CA 91320. May 2010. 2. Scott SD. Dose conversion from recombinant

human erythropoietin to darbepoetin alfa: recommendations from clinical studies. Pharmacotherapy 2002;22:160S-165S.

3. Tolman C, Richardson D, Bartlett C, Will E. Structured conversion from thrice weekly to once weekly erythropoietic regimens using a computerized support system: a randomized clinical study. J Am Soc Nephrol 2005;16:1463-70.

4. Sterner G, Prutz KG. Conversion from epoetin beta to darbepoetin: what is the equivalent dose? Nephrol Dial Transplant 2008;23:4084-5.

5. Bock HA, Hirt-Minkowski P, Brunisholz M, et al. Darbepoetin alpha in lower-than-equimolar doses maintains haemoglobin levels in stable haemodialysis patients converting from epoetin alpha/beta. Nephrol Dial Transplant 2008;23:301-8.

6. Roger SD, Cooper B. What is the practical conversion dose when changing from epoetin alfa to darbepoetin outside of clinical trials? Nephrology 2004;9:223-8.

7. Horowitz J, Agarwal A, Huang F, et al. Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. J Manag Care Pharm 2009;15:741-50.

(Detail-Document #261213: Page 3 of 3)

8. Rizzo JD, Brouwers M, Hurley P, et al. American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer. J Clin Oncol 2010;28:4996-5010.

Cite this Detail-Document as follows: Dose conversions for epoetin and darbepoetin. Pharmacist’s Letter/Prescriber’s Letter 2010;26(12):261213.

Evidence and Advice You Can Trust…

3120 West March Lane, P.O. Box 8190, Stockton, CA 95208 ~ TEL (209) 472-2240 ~ FAX (209) 472-2249 Copyright © 2010 by Therapeutic Research Center

Subscribers to Pharmacist’s Letter and Prescriber’s Letter can get Detail-Documents, like this one, on any

topic covered in any issue by going to www.pharmacistsletter.com or www.prescribersletter.com

PL Detail-Document #280408

−This Detail-Document accompanies the related article published in− PHARMACIST’S LETTER / PRESCRIBER’S LETTER

April 2012



Drugs with REMS and Other Special Prescribing/Dispensing Requirements

Some prescription and OTC drugs have special requirements when they are prescribed or dispensed. Usually, the reason for this is to improve

patient safety. Newer requirements mandated by FDA are called Risk Evaluation and Mitigation Strategies, or REMS. REMS may be as simple as dispensing a Medication Guide, or more involved with components such as training courses for health care professionals and registries for patients. REMS didn’t come to be until 2007, with the Food and Drug Administration Amendments Act (FDAAA). Drugs with MedGuides and/or special requirements that were in place before 2007 are not technically REMS drugs; at least not yet. Prior to the FDAAA, the programs were referred to as risk minimization action plans, or RiskMAPs. This is the case with Clozaril, which can cause agranulocytosis. FDA is in the process of converting RiskMAPs to REMS. Other special requirements are mandated by federal law. For example, individuals must be at least 18 years of age to purchase nicotine products. Vaccine information statements (VIS) are given to patients before administration of a vaccine. Sometimes, drugs that are used for relatively rare diseases are available only through certain pharmacies, as with some treatments for pulmonary hypertension. This chart lists drugs with special prescribing or dispensing requirements.

PLEASE NOTE: Drugs with only a MedGuide as part of their REMS program are not included in the following chart. A complete list of drugs that require a MedGuide is available in our PL Chart, Drug Products with Medication Guides. Drugs with REMS programs which only require action by the manufacturer (i.e., communication plans) are also not included in the chart below. The full listing of REMS-classified drugs is available at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.

(Information pertains to U.S. products) Drug Name

Rationale for Special

Requirements

Special Requirements

Contact Information

Abstral (fentanyl

sublingual tablet)

Abstral has the potential for

misuse, abuse, addiction, and

overdose.

•Prescribers must be enrolled in the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program to prescribe Abstral for outpatient use. •Patients (outpatients only) must be enrolled in the TIRF REMS Access program. Enrollment occurs when first Abstral prescription is filled. •Pharmacies (outpatient and inpatient) must enroll in the TIRF REMS Access program. •Patient and prescriber enrollment not required for inpatient use of Abstral. •Wholesalers must enroll in the TIRF REMS Access program.

www.TIRFREMSaccess.com 866-822-1483

(PL Detail-Document #280408: Page 2 of 10)



Drug Name


Requirements


Contact Information

Accutane, others (isotretinoin)

(As of September 2010, Accutane

brand is no longer available.)

Isotretinoin is highly teratogenic.

•Prescribers and patients must register with iPLEDGE to prescribe or obtain prescriptions for isotretinoin. •Patients taking isotretinoin must have monthly pregnancy tests and confirm the use of two separate forms of birth control. •Pharmacists must get authorization from the iPLEDGE system through the website or phone system before dispensing isotretinoin for either male or female patients. •Wholesalers and pharmacies must register to order, distribute, or receive isotretinoin.

www.iPledgeProgram.com 866-495-0654

Actiq (fentanyl lozenge)

Actiq has the potential for


overdose.

Same special requirements as for Abstral (see above). (Per the FDA, Actiq generics are required to have a REMS with the same elements as that approved for Actiq.)1

www.TIRFREMSaccess.com 866-822-1483

Avandia, Avandamet, and

Avandaryl (rosiglitazone-

containing products)

Rosiglitazone can increase the risk of

heart attack.

•Prescribers and patients must enroll in the Avandia-Rosiglitazone Medicines Access Program. •Rosiglitazone-containing products will only be available from specially certified pharmacies.

www.avandia.com 800-282-6342

Butrans (buprenorphine

transdermal)

Buprenorphine has the potential for misuse, abuse, addiction, and

overdose.

•Prescribers receive training. www.butransrems.com

Caprelsa (vandetanib)

Vandetanib can increase the risk of QT prolongation,

torsades de pointes, and sudden death.

•Prescribers and pharmacies must enroll in the Caprelsa REMS Program to prescribe and dispense vandetanib.

www.caprelsarems.com 800-817-2722




Drug Name


Requirements


Contact Information

CellCept, Myfortic (mycophenolate)

Mycophenolate is associated with increased risk of

pregnancy loss and congenital

malformations.

•Women of childbearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within one week prior to beginning therapy. •Women of childbearing potential taking mycophenolate must receive contraceptive counseling and use effective contraception. •The patient should begin using her two chosen methods of contraception four weeks prior to starting mycophenolate therapy, unless abstinence is the chosen method. •Contraceptives should be used during and for six weeks after stopping mycophenolate.

CellCept: Genentech at 800-821-8590 Myfortic: Novartis at 888-669-6682

Clozaril (clozapine)

Clozapine can cause

agranulocytosis.

•Prescribers must register with the Clozaril National Registry (CNR). The prescriber is responsible for registering patients. •The prescriber must obtain a white blood cell count (WBC) and an absolute neutrophil count (ANC) value for the patient. The pharmacist must be supplied with this info (drawn within seven days) before dispensing. •Pharmacies that dispense Clozaril must be registered with CNR to purchase Clozaril from a wholesaler. •Pharmacists must verify that patients with prescriptions for Clozaril are registered with CNR prior to dispensing.

www.clozaril.com/hcp/treating/background.jsp 800-448-5938

Darbepoetin (Aranesp) Epoetin

(Epogen, Procrit)

Increased risk of cardiovascular events, death,

thromboembolic events, stroke, and increased risk of

tumor progression or recurrence in

patients with cancer.

•Oncology prescribers must train and enroll in the Erythropoiesis Stimulating Agents (ESA) Assisting Providers and cancer Patients with Risk Information for the Safe use of ESAs (APPRISE) Oncology program. Prescribers and oncology patients must sign the ESA APPRISE Oncology Program Patient and Healthcare Professional Acknowledgement Form before each course of therapy. •Hospitals must have a site designee (pharmacy director or head of hematology/oncology) certified by the ESA APPRISE program. •The APPRISE program and Acknowledgement Form only apply to oncology uses of the products, but all patients (including inpatients) who receive these drugs must be given a MedGuide.

www.esa-apprise.com 866-284-8089




Drug Name


Requirements


Contact Information

Entereg (alvimopan)

Entereg can increase the risk of heart attacks when used for more than

15 doses.

•Hospital-based health care providers (i.e., nurses, pharmacists, prescribers) must review Entereg Access Support & Education (E.A.S.E.) materials. •Hospitals must register with E.A.S.E. This can be done by a hospital pharmacist, P&T committee representative, etc. •Entereg is only available to hospitals with E.A.S.E. certification and may not be dispensed to outpatients.

www.entereg.com/content/rems/ 866-423-6567

Exalgo (hydromorphone extended-release)

Exalgo has the potential for


overdose.

•Prescribers are encouraged to complete the Exalgo REMS Education program.

www.exalgorems.com 888-939-2546

Extraneal (icodextrin

peritoneal dialysis solution)

Icodextrin contains maltose which can react with certain

blood glucose monitors and test

strips to cause false readings.

•Dialysis clinic staff must complete training on drug-device interactions involving Extraneal. •Patient training required (completed by dialysis clinic staff).

847-473-6590

Fentora (fentanyl buccal

tablet)

Fentora has the potential for


overdose.

Same special requirements as for Abstral (see above). www.TIRFREMSaccess.com 866-822-1483

Lazanda (fentanyl nasal

spray)

Lazanda has the potential for


overdose.





Drug Name


Requirements


Contact Information

Letairis (ambrisentan)

Ambrisentan can cause birth defects.

•Prescribers and pharmacies must enroll in the Letairis Education and Access Program (LEAP). •Prescribers must enroll their patients in LEAP initially and every 12 months.

www.letairisrems.com 866-664-5327

Lotronex (alosetron)

Alosetron can cause severe GI

effects, like ischemic colitis and

serious complications of

constipation.

•Only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have chronic IBS symptoms lasting six months or more, have had anatomic or biochemical abnormalities of the GI tract excluded, and who have not responded to conventional therapy. •Prescribers must be enrolled in the Prescribing Program for Lotronex (PPL). •Patients must sign a Patient Acknowledgement Form. •Pharmacists can only dispense prescriptions that have a PPL Sticker. •Telephone orders, faxed orders, or computer-generated prescriptions are not allowed. •Refills are permitted on written prescriptions.

For enrollment in the PPL: www.lotronexppl.com/Physicians/

Prescribing/ 888-423-5227

Lumizyme (alglucosidase

alfa)

Alglucosidase alfa can cause

anaphylaxis and severe allergic

reactions.

•Prescribers must be certified in the Lumizyme Alglucosidase Alfa Control and Education (ACE) program, and enroll their patients. •Health care facilities must be certified in the Lumizyme ACE program.

www.lumizyme.com 800-745-4447

Methadone 40 mg tablets

Methadone 40 mg is indicated

for detox and maintenance

treatment of opioid-addicted patients.

It’s not FDA-approved for pain.

•As of January 1, 2008, methadone 40 mg is only available to hospitals and facilities that have been authorized for detoxification and maintenance treatment of patients with opioid addiction. •Federal law does not restrict the prescribing, dispensing, or administration of methadone for the treatment of pain. The 5 mg and 10 mg methadone formulations continue to be available for the treatment of pain.

Roxane 800-962-8364




Drug Name


Requirements


Contact Information

Mifeprex (mifepristone)

Mifeprex can cause serious and

sometime fatal infections and

bleeding.

•Prescribers must enroll in the Mifeprex REMS program. •Patients must complete and sign a patient agreement. •Mifeprex will only be dispensed in clinics, medical offices, and hospitals. It will not be dispensed through retail pharmacies. •Distributor will be certified and only distribute drug to locations specified by the enrolled prescriber.

www.earlyoptionpill.com 877-432-7596

Nicotine (e.g., Commit,

Habitrol, Nicorette, etc)

FDA prohibits sale of nicotine products

to individuals younger than 18

years of age.

•Patients must show identification for proof of age prior to purchase of nicotine products.

None

Nucynta ER (tapentadol ER)

Nucynta ER has the potential for


overdose.

•Prescribers are encouraged to complete the Nucynta ER Healthcare Professional Education program.

www.nucyntaerrems.com 800-526-7736

Onsolis (fentanyl buccal

soluble film)

Onsolis has the potential for


overdose.


Opana ER (oxymorphone)

Opana ER has the potential for


overdose.

•Prescribers are encouraged to complete the Opana ER Healthcare Professional Education program.

www.opanaerrems.com 800-462-3636




Drug Name


Requirements


Contact Information

Opioids (extended-release and long-acting)

Extended-release and long-acting opioids have the

potential for misuse, abuse, addiction, and

overdose.

•REMS programs not expected to be in place for most products until early 2012. These programs will consist of prescriber and patient education. (Individual opioid products with existing REMS programs are listed separately in this chart.)

None

OxyContin (oxycodone

controlled-release)

OxyContin has the potential for


overdose.

•Prescribers are encouraged to complete the OxyContin Healthcare Provider Training guide.

www.oxycontinrems.com 888-726-7535

Plan B, Plan B One-Step,

Next Choice (levonorgestrel)

Federal law prohibits the OTC

sale of these to patients under 17

years of age.

•Must be stocked behind the counter. •OTC for patients 17 years of age and older. •Rx for patients younger than 17 years.

None

Propulsid (cisapride)

Cisapride was withdrawn from the market because it

can cause fatal arrhythmias.

•Available only through an investigational limited access program for specific conditions, including gastroparesis, severe chronic constipation, and feeding intolerance in neonates. •Patients must meet strict criteria for enrollment. •Institutional review board approval, completion of a Form FDA 1572, and signed informed consent are required for use.

www.propulsid-lap.com 877-795-4247

Pseudoephedrine Pseudoephedrine is scheduled by the

Controlled Substances Act as a methamphetamine

precursor.

•Must be kept behind the counter. •Patients must show identification and sign a log book to purchase. •A maximum of 3.6 grams per day and 9 grams per month may be purchased from a retail pharmacy by an individual. •If state laws are stricter than federal laws, state laws must be followed.

None




Drug Name


Requirements


Contact Information

Qualaquin (quinine)

Quinine is not FDA-approved for the treatment of leg cramps. Quinine

can cause thrombocytopenia.

•Legal experts suggest the use of an informed consent form for prescribers to use when prescribing quinine off-label to treat leg cramps.

None

Revlimid (lenalidomide)

Lenalidomide can cause birth defects.

•Prescribers must be certified in the RevAssist program, and register their patients. •Pharmacies must be certified in RevAssist program.

www.revlimid.com 888-423-5436

Sabril (vigabatrin)

Vigabatrin can cause vision loss.

•Prescribers must be certified, and enroll patients in the Support, Help and Resources for Epilepsy (SHARE) program. •Pharmacies must be certified.

www.lundbeckshare.com 888-457-4273

Soliris (eculizumab)

Eculizumab can increase the risk for

meningococcal infection.

•Prescribers must be certified, and enroll patients in the OneSource Safety Support Program.

www.soliris.net 888-765-4747

Suboxone (sublingual

buprenorphine/ naloxone film and

tablets)

Subutex (sublingual

buprenorphine tablets)

Buprenorphine is indicated for

detoxification from narcotic addiction.

•Prescribers must get a Drug Addiction Treatment Act (DATA 2000) waiver to become certified to prescribe Suboxone for office-based treatment of opioid dependence. This involves completion of an approved eight-hour CME course and notification of the government of the intent to use Suboxone or Subutex to treat opioid-dependent patients. •Prescriptions should contain both the prescriber’s DEA number and the Unique Identification Number (UIN) which indicates the prescriber has a DATA waiver. This UIN begins with an “X.” •Pharmacists should verify that a prescriber has a DATA waiver.

For prescribers to obtain a DATA 2000 waiver:

www.suboxone.com/hcp/certification/

For physicians in each state who have DATA 2000 waivers (note the list is not always complete):

www.buprenorphine.samhsa.gov

To verify that a physician has a valid DATA 2000 waiver:

866-287-2728 or email [email protected]




Drug Name


Requirements


Contact Information

Subsys (fentanyl

sublingual spray)

Subsys has the potential for


overdose.


Thalomid (thalidomide)

Thalidomide is teratogenic.

•Prescribers and pharmacies must be registered with the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) to prescribe or dispense Thalomid. Prescribers must register patients.

www.thalomid.com/steps_program.aspx

888-423-5436 Tikosyn

(dofetilide) Dofetilide can cause serious ventricular

arrhythmias, like torsades de pointes.

•Prescribers must enroll in the Tikosyn REMS program. •Pharmacies must enroll in the Tikosyn REMS program. •Health care settings where Tikosyn is dispensed must be enrolled in the Tikosyn REMS program.

www.tikosynrems.com 877-845-6796

Tracleer (bosentan)

Bosentan has serious side effects

such as hepatotoxicity.

•Prescribers must be certified, and enroll patients in the Tracleer Access Program (T.A.P.). •Dispensers must be certified.

www.tracleer.com/Hcp-Prescribing-Tracleer-Tracleer-

Access-Program 866-228-3546

Tysabri

(natalizumab) Natalizumab can cause progressive

multifocal leukoencephal-

opathy (PML), a rare viral brain

infection.

•Patients and prescribers must be enrolled in the Tysabri Outreach: Unified Commitment to Health (TOUCH) Prescribing program. •Pharmacies and infusion centers must be registered with the TOUCH Prescribing Program to dispense or infuse Tysabri. This program has two components: MS TOUCH (for patients with multiple sclerosis) and CD TOUCH (for patients with Crohn’s disease).

www.tysabri.com 800-456-2255

Zyprexa Relprevv (olanzapine

extended-release injectable

suspension)

Zyprexa Relprevv can cause post-

injection delirium/sedation.

•Prescribers and dispensers must be certified. Prescribers must enroll patients.

www.zyprexarelprevvprogram.com 877-772-9390


Users of this PL Detail-Document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national organizations. Information and Internet links in this article were current as of the date of publication. Project Leaders in preparation of this Detail-Document: Stacy A. Hester, R.Ph., BCPS, Assistant Editor (Original November 2010); Kim Palacioz, Pharm.D., Associate Editor (April 2012 update)

Reference 1. Personal communication (written). Y. Fultz-Morris.

Center for Drug Evaluation and Research. FDA. October 24, 2011.

Cite this document as follows: PL Detail-Document, Drugs with REMS and Other Special Prescribing/Dispensing Requirements. Pharmacist’s Letter/Prescriber’s Letter. April 2012.

Evidence and Recommendations You Can Trust…

3120 West March Lane, P.O. Box 8190, Stockton, CA 95208 ~ TEL (209) 472-2240 ~ FAX (209) 472-2249 Copyright © 2012 by Therapeutic Research Center

Subscribers to Pharmacist’s Letter and Prescriber’s Letter can get PL Detail-Documents, like this one, on any topic covered in any issue by going to www.pharmacistsletter.com or www.prescribersletter.com