DOSAGE AND ADMINISTRATION
Myorisan should be administered with a meal (see PATIENT INFORMATION).
The recommended dosage range for Myorisan is 0.5 to 1
mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies
comparing 0.1, 0.5, and 1 mg/kg/day,8 it was found that all dosages provided
initial clearing of disease, but there was a greater need for retreatment with
the lower dosages. During treatment, the dose may be adjusted according to
response of the disease and/or the appearance of clinical side effects - some
of which may be dose related. Adult patients whose disease is very severe with
scarring or is primarily manifested on the trunk may require dose adjustments
up to 2 mg/kg/day, as tolerated. Failure to take Myorisan with food will
significantly decrease absorption. Before upward dose adjustments are made, the
patients should be questioned about their compliance with food instructions.
The safety of once daily dosing with Myorisan has not
been established. Once daily dosing is not recommended.
If the total nodule count has been reduced by more than
70% prior to completing 15 to 20 weeks of treatment, the drug may be
discontinued. After a period of 2 months or more off therapy, and if warranted
by persistent or recurring severe nodular acne, a second course of therapy may
The optimal interval before retreatment has not been
defined for patients who have not completed skeletal growth. Long-term use of
Myorisan, even in low doses, has not been studied, and is not recommended. It
is important that Myorisan be given at the recommended doses for no longer than
the recommended duration. The effect of long-term use of Myorisan on bone loss
is unknown (see WARNINGS: Skeletal: Bone Mineral Density,
Hyperostosis, and Premature Epiphyseal Closure).
Contraceptive measures must be followed for any
subsequent course of therapy (see PRECAUTIONS).
Table 4 : Myorisan Dosing by Body Weight (Based on
Administration With Food)
||2 mg/kg *
|*See DOSAGE AND ADMINISTRATION: the recommended
dosage range is 0.5 to 1 mg/kg/day.
INFORMATION FOR PHARMACISTS
Access the iPLEDGE system via the internet
(www.ipledgeprogram.com) or telephone (1-866- 495-0654) to obtain an
authorization and the “do not dispens e to patient after” date.
Myorisan must only be dispensed in no more than a 30-day supply.
REFILLS REQUIRE A NEW PRESCRIPTION AND A NEW
AUTHORIZATION FROM THE iPLEDGE SYSTEM.
A Myorisan Medication Guide must be given to the patient
each time Myorisan is dispensed, as required by law. This Myorisan Medication
Guide is an important part of the risk management program for the patient.
Soft gelatin capsules, 10 mg (pale yellow), imprinted in
black ink with “V10”. Boxes of 30 containing 3 Prescription Packs of 10
capsules (NDC 61748-301-13). Boxes of 100 containing 10 Prescription Packs of
10 capsules (NDC 61748-301-11). Soft gelatin capsules, 20 mg (white to slight
pink), imprinted in black ink with “V20”. Boxes of 30 containing 3 Prescription
Packs of 10 capsules (NDC 61748-302-13). Boxes of 100 containing 10
Prescription Packs of 10 capsules (NDC 61748-302-11). Soft gelatin capsules, 30
mg (pink), imprinted in black ink with “V30”. Boxes of 30 containing 3 Prescription
Packs of 10 capsules (NDC 61748-303-13). Boxes of 100 containing 10 Prescription
Packs of 10 capsules (NDC 61748-303-11). Soft gelatin capsules, 40 mg (orange),
imprinted in black ink with “V40”. Boxes of 30 containing 3 Prescription Packs
of 10 capsules (NDC 61748-304-13). Boxes of 100 containing 10 Prescription
Packs of 10 capsules (NDC 61748-304-11).
Store at 20°-25°C (68° to 77°F). [See USP controlled
room temperature]. Protect from light.
Patient Information/Informed Consent About Birth
Defects (for female patients who can get pregnant)
To be completed by the patient (and her parent or
guardian* if patient is under age 18) and signed by her doctor.
Read each item below and initial in the space provided to
show that you understand each item and agree to follow your doctor's
instructions. Do not sign this consent and do not take isotretinoin if there
is anything that you do not understand.
*A parent or guardian of a minor patient (under age 18)
must also read and initial each item before signing the consent.
1. I understand that there is a very high chance that my
unborn baby could have severe birth defects if I am pregnant or become pregnant
while taking isotretinoin. This can happen with any amount and even if taken
for short periods of time. This is why I must not be pregnant while taking
2. I understand that I must not get pregnant one month
before, during the entire time of my treatment, and for one month after the end
of my treatment with isotretinoin.
3. I understand that I must avoid sexual intercourse
completely, or I must use two separate, effective forms of birth control
(contraception) at the same time. The only exceptions are if I
have had surgery to remove the uterus (a hysterectomy) or both of my ovaries
(bilateral oophorectomy), or my doctor has medically confirmed that I am
4. I understand that hormonal birth control products are
among the most effective forms of birth control. Combination birth control
pills and other hormonal products include skin patches, shots, under-the-skin implants,
vaginal rings, and intrauterine devices (IUDs). Any form of birth control can
fail. That is why I must use two different birth control methods at the same
time, starting one month before, during, and for one month after stopping
therapy every time I have sexual intercourse, even if one of the methods I choose
is hormonal birth control.
5. I understand that the following are effective forms of
- tying my tubes (tubal sterilization)
- partner's vasectomy
- intrauterine device
- hormonal (combination birth control pills, skin patches,
shots, under-the-skin implants or vaginal ring)
- male latex condom with or without spermicide
- diaphragm with spermicide
- cervical cap with spermicide
- vaginal sponge (contains spermicide)
A diaphragm and cervical cap must each be used with
spermicide, a special cream that kills sperm.
I understand that at least one of my two forms of birth
control must be a primary method.
6. I will talk with my doctor about any medicines
including herbal products I plan to take during my isotretinoin treatment
because hormonal birth control methods may not work if I am taking certain medicines
or herbal products.
7. I may receive a free birth control counseling session
from a doctor or other family planning expert. My isotretinoin doctor can give
me an isotretinoin Patient Referral Form for this free consultation.
8. I must begin using the birth control methods I have
chosen as described above at least one month before I start taking
9. I cannot get my first prescription for isotretinoin
unless my doctor has told me that I have two negative pregnancy test results.
The first pregnancy test should be done when my doctor decides to prescribe
isotretinoin. The second pregnancy test must be done in a lab during the first
5 days of my menstrual period right before starting isotretinoin therapy
treatment, or as instructed by my doctor. I will then have one pregnancy test;
in a lab.
- every month during treatment
- at the end of treatment
- and 1 month after stopping treatment
I must not start taking isotretinoin until I am sure that
I am not pregnant, have negative results from two pregnancy tests, and the
second test has been done in a lab.
10. I have read and understand the materials my doctor
has provided to me, including The Ipledge Program Guide for Isotretinoin for
Female Patients Who Can Get Pregnant, The iPLEDGE Birth Control Workbook and The
iPLEDGE Program Patient Introductory Brochure.
My doctor provided me and asked me to watch a video about
birth control and a video about birth defects and isotretinoin.
I was told about a private counseling line that I may
call for more information about birth control. I have received information on
emergency birth control.
11. I must stop taking isotretinoin right away and call
my doctor if I get pregnant, miss my expected menstrual period, stop using
birth control, or have sexual intercourse without using my two birth control
methods at any time.
12. My doctor provided me information about the purpose
and importance of providing information to the iPLEDGE Program should I become
pregnant while taking isotretinoin or within one month of the last dose. I
understand that if I become pregnant, information about my pregnancy, my
health, and my baby's health may be shared with the makers of isotretinoin,
authorized parties who maintain the iPLEDGE Program for the makers of
isotretinoin and government health regulatory authorities.
13. I understand that being qualified to receive
isotretinoin in the iPLEDGE Program means that I:
- have had two negative urine or blood pregnancy tests
before receiving the first isotretinoin prescription. The second test must be
done in a lab. I must have a negative result from a urine or blood pregnancy
test done in a lab repeated each month before I receive another isotretinoin
- have chosen and agreed to use two forms of effective
birth control at the same time. At least one method must be a primary form of
birth control, unless I have chosen never to have sexual contact with a male
(abstinence), or I have undergone a hysterectomy. I must use two
forms of birth control for at least one month before I start isotretinoin
therapy, during therapy, and for one month after stopping therapy. I must
receive counseling, repeated on a monthly basis, about birth control and
behaviors associated with an increased risk of pregnancy.
- have signed a Patient Information/Informed Consent About
Birth Defects (for female patients who can get pregnant) that contains warnings
about the chance of possible birth defects if I am pregnant or become pregnant
and my unborn baby is exposed to isotretinoin.
- have been informed of and understand the purpose and
importance of providing information to the iPLEDGE Program should I become
pregnant while taking isotretinoin or within 1 month of the last dose.
- have interacted with the iPLEDGE Program before starting
isotretinoin and on a monthly basis to answer questions on the program
requirements and to enter my two chosen forms of birth control.
My doctor has answered all my questions about isotretinoin
and I understand that it is my responsibility not to get pregnant one month
before, during isotretinoin treatment, or for one month after I s top taking isotretinoin.
I now authorize my doctor ________________ to begin my
treatment with isotretinoin.
Parent/Guardian Signature (if under age
Please print: Patient Name and
I have fully explained to the patient,
__________________, the nature and purpose of the treatment described above and
the risks to females of reproductive potential. I have asked the patient if she
has any questions regarding her treatment with isotretinoin and have answered
those questions to the best of my ability.
Doctor Signature: ____________________________________
PLACE THE ORIGINAL SIGNED DOCUMENTS IN THE PATIENT'S
MEDICAL RECORD. PLEASE PROVIDE A COPY TO THE PATIENT.
Patient Information/Informed Consent (for all patients
To be completed by patient (and parent or guardian if
patient is under age 18) and signed by the doctor.
Read each item below and initial in the space provided if
you understand each item and agree to follow your doctor's instructions. A
parent or guardian of a patient under age 18 must also read and understand each
item before signing the agreement.
Do not sign this agreement and do not take isotretinoin
if there is anything that you do not understand about all the information you
have received about using isotretinoin.
understand that isotretinoin is a medicine used to treat
severe nodular acne that cannot be cleared up by any other acne treatments,
including antibiotics. In severe nodular acne, many red, swollen, tender lumps form
in the skin. If untreated, severe nodular acne can lead to permanent scars.
2. My doctor has told me about my choices for treating my
3. I understand that there are serious side effects that
may happen while I am taking isotretinoin. These have been explained to me.
These side effects include serious birth defects in babies of pregnant patients.
[Note: There is a second Patient Information/Informed Consent About Birth
Defects (for female patients who can get pregnant)].
4. I understand that some patients, while taking
isotretinoin or soon after stopping isotretinoin, have become depressed or
developed other serious mental problems. Symptoms of depression include sad, “anxious”
or empty mood, irritability, acting on dangerous impulses, anger, loss of
pleasure or interest in social or sports activities, sleeping too much or too
little, changes in weight or appetite, school or work performance going down,
or trouble concentrating. Some patients taking isotretinoin have had thoughts
about hurting themselves or putting an end to their own lives (suicidal
thoughts). Some people tried to end their own lives. And some people have ended
their own lives. There were reports that some of these people did not appear
depressed. There have been reports of patients on isotretinoin becoming aggressive
or violent. No one knows if isotretinoin caused these behaviors or if they
would have happened even if the person did not take isotretinoin. Some people
have had other signs of depression while taking isotretinoin (see #7 below).
5. Before I start taking isotretinoin, I agree to tell my
doctor if I have ever had symptoms of depression (see #7 below), been
psychotic, attempted suicide, had any other mental problems, or take medicine
for any of these problems. Being psychotic means having a loss of contact with
reality, such as hearing voices or seeing things that are not there.
6. Before I start taking isotretinoin, I agree to tell my
doctor if, to the best of my knowledge, anyone in my family has ever had
symptoms of depression, been psychotic, attempted suicide, or had any other serious
7. Once I start taking isotretinoin, I agree to stop
using isotretinoin and tell my doctor right away if any of the following signs
and symptoms of depression or psychosis happen. I:
- Start to feel sad or have crying spells
- Lose interest in activities I once enjoyed
- Sleep too much or have trouble sleeping
- Become more irritable, angry, or aggressive than usual
(for example, temper outbursts, thoughts of violence)
- Have a change in my appetite or body weight
- Have trouble concentrating
- Withdraw from my friends or family
- Feel like I have no energy
- Have feelings of worthlessness or guilt
- Start having thoughts about hurting myself or taking my
own life (suicidal thoughts)
- Start acting on dangerous impulses
- Start seeing or hearing things that are not real
8. I agree to return to see my doctor every month I
take isotretinoin to get a new prescription for isotretinoin, to check my
progress, and to check for signs of side effects.
9. Isotretinoin will be prescribed just for me - I will
not share isotretinoin with other people because it may cause serious side
effects, including birth defects.
10. I will not give blood while taking isotretinoin or
for 1 month after I stop taking isotretinoin. I understand that if someone who
is pregnant gets my donated blood, her baby may be exposed to isotretinoin and
may be born with serious birth defects.
11. I have read The iPLEDGE Program Patient Introductory
Brochure, and other materials my provider provided me containing important
safety information about isotretinoin. I understand all the information I received.
12. My doctor and I have decided I should take
isotretinoin. I understand that I must be qualified in the iPLEDGE Program to
have my prescription filled each month. I understand that I can stop taking isotretinoin
at any time. I agree to tell my doctor if I stop taking isotretinoin.
I now allow my doctor ___________________________ to
begin my treatment with isotretinoin.
Patient Signature: ____________________________________
Parent/Guardian Signature (if under age 18):
_______________ Date: ______
Patient Name (print) ___________________________________
Patient Address ___________________________ Telephone
- fully explained to the patient, __________________, the
nature and purpose of isotretinoin treatment, including its benefits and risks
- provided the patient with the appropriate educational
materials, The iPLEDGE Program Patient Introductory Brochure and asked the
patient if he/she has any questions regarding his/her treatment with isotretinoin
- answered those questions to the best of my ability
Doctor Signature: _________________________________ Date:
PLACE THE ORIGINAL SIGNED DOCUMENTS IN THE PATIENT'S
MEDICAL RECORD. PLEASE PROVIDE A COPY TO THE PATIENT.
1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged
remissions of cystic and conglobate acne with 13-cis-retinoic acid. N Engl J
Med 300:329-333, 1979.
2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report
of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500,
3. Farrell LN, Strauss JS, Stranieri AM. The treatment of
severe cystic acne with 13-cis-retinoic acid: evaluation of sebum production
and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611,
4. Jones H, Blanc D, Cunliffe WJ. 13-cis-retinoic acid
and acne. Lancet 2:1048-1049, 1980.
8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin
therapy for acne: results of a multicenter doseresponse study. J Am Acad
Dermatol 10:490-496, 1984.
Distributed by: VersaPharm Inc. - An Akorn Company, Lake
Forest, IL 60045. Revised: Sep 2015