“Teva’s first-to-market generic model of Absorica® (isotretinoin) capsules within the U.S. is a crucial remedy choice for sufferers dwelling with extreme recalcitrant nodular pimples, and who’re unresponsive to standard pimples remedy, together with antibiotics,” stated Christine Baeder, SVP, Chief Working Officer US Generics, Teva USA. “With greater than 30 dermatological merchandise in Teva’s generics portfolio, we’re proud so as to add one other accessible choice for sufferers.”
With almost 550 generic medicines obtainable, Teva has the most important portfolio of FDA-approved generic merchandise in the marketplace and holds the main place in first-to-file alternatives, with roughly 100 pending first-to-files within the U.S. At the moment, 1 in 11 generic prescriptions disbursed within the U.S. is crammed with a Teva generic product.
Isotretinoin oral capsules have annual gross sales of greater than $158 million within the U.S., in response to IQVIA information as of February 2021.
About Isotretinoin Oral Capsules
Isotretinoin capsules are prescription medicines utilized in sufferers 12 years of age and older, who should not pregnant, for the remedy of extreme pimples (nodular pimples) that can not be cleared up by some other pimples remedies, together with antibiotics.
It’s not recognized if isotretinoin capsules are protected and efficient in youngsters lower than 12 years of age.
IMPORTANT SAFETY INFORMATION
What’s a very powerful info I ought to find out about isotretinoin capsules?
- Isotretinoin capsules can hurt your unborn child, together with delivery defects (deformed infants), lack of a child earlier than delivery (miscarriage), demise of the child, and early (untimely) births. Sufferers who’re pregnant or who plan to change into pregnant should not take isotretinoin capsules.
Sufferers should not get pregnant:
- for 1 month earlier than beginning isotretinoin capsules
- throughout remedy with isotretinoin capsules
- for 1 month after stopping isotretinoin capsules
In the event you get pregnant throughout remedy with isotretinoin capsules, cease taking it immediately and name your healthcare supplier. Healthcare suppliers and sufferers ought to report all instances of being pregnant throughout remedy or 1 month after stopping remedy to:
As a result of isotretinoin capsules could cause delivery defects, isotretinoin capsules are just for sufferers who can perceive and agree to hold out all the directions within the iPLEDGE Program.
- Severe psychological well being issues, together with:
- psychosis(seeing or listening to issues that aren’t actual)
- suicide. Some sufferers taking isotretinoin capsules have had ideas about hurting themselves or placing an finish to their very own lives (suicidal ideas). Some folks tried to finish their very own lives. Some folks have ended their very own lives.
Cease taking isotretinoin capsules and name your healthcare supplier immediately in case you or a member of the family notices that you’ve got any of the next indicators and signs of melancholy or psychosis:
- begin to really feel unhappy or have crying spells
- lose curiosity in actions you as soon as loved
- sleep an excessive amount of or have hassle sleeping
- change into extra irritable, offended, or aggressive than regular (for instance, mood outbursts, ideas of violence)
- have a change in your urge for food or physique weight
- have hassle concentrating
- withdraw from your mates or household
- really feel like you haven’t any power
- have emotions of worthlessness or guilt
- begin having ideas about hurting your self or taking your personal life (suicidal ideas)
- begin performing on harmful impulses
- begin seeing or listening to issues that aren’t actual
Your healthcare supplier could inform you to see a psychological healthcare skilled in case you had any of those signs.
Don’t take isotretinoin capsules in case you:
- are pregnant, plan to change into pregnant, or change into pregnant throughout isotretinoin capsules remedy. Isotretinoin capsules trigger extreme delivery defects. See “What’s a very powerful info I ought to find out about isotretinoin capsules?”
- are allergic to isotretinoin, vitamin A, or any of the components in isotretinoin capsules. See the tip of the Medicine Information within the full Prescribing Data for a whole checklist of components in isotretinoin capsules.
Earlier than taking isotretinoin capsules, inform your healthcare supplier in case you or a member of the family has any of the next well being situations:
- psychological well being issues
- bronchial asthma
- liver issues
- coronary heart illness
- enhance blood fats ranges (ldl cholesterol and triglycerides)
- bone loss (osteoporosis), weak bones or some other bone issues
- an consuming drawback known as anorexia nervosa (the place folks eat too little)
- meals or medication allergy symptoms, together with aspirin or tartrazine
Inform your healthcare supplier in case you are pregnant or breastfeeding. Don’t breastfeed throughout remedy or for a minimum of 8 days after the final dose of isotretinoin capsules.
Inform your healthcare supplier about all the medicines you’re taking together with prescription and over-the-counter medicines, nutritional vitamins and natural dietary supplements, together with St. John’s wort. Isotretinoin capsules and sure different medicines can have an effect on one another, generally inflicting severe negative effects.
Don’t take the next medicines throughout remedy with isotretinoin capsules:
- vitamin A dietary supplements
- tetracycline antibiotics
Know the medicines you’re taking. Preserve an inventory of them to indicate to your healthcare supplier and pharmacist. Don’t take any new medication with out speaking together with your healthcare supplier.
What ought to I keep away from whereas taking isotretinoin capsules?
- Don’t give blood throughout remedy with isotretinoin capsules and for one month after stopping isotretinoin capsules. If somebody who’s pregnant will get your donated blood, their child could also be uncovered to isotretinoin and could also be born with delivery defects.
- Don’t take different medicines or natural merchandise with isotretinoin capsules until you discuss to your healthcare supplier. See “Earlier than taking isotretinoin capsules”
- Don’t drive at evening till you understand if isotretinoin capsules have affected your imaginative and prescient. Isotretinoin capsules could lower your capacity to see at nighttime.
- Wouldn’t have beauty procedures to clean your pores and skin, together with waxing, dermabrasion, or laser procedures, throughout remedy with isotretinoin capsules and for a minimum of 6 months after you cease. Isotretinoin capsules can enhance your probability of scarring from these procedures. Verify together with your healthcare supplier for recommendation about when you may have beauty procedures.
- Keep away from daylight and ultraviolet lights as a lot as doable. Tanning machines use ultraviolet lights. Isotretinoin capsules could make your pores and skin extra delicate to mild.
- Don’t share isotretinoin capsules with different folks. Isotretinoin capsules could cause delivery defects and different severe well being issues.
What are the doable negative effects of isotretinoin capsules?
Isotretinoin capsules could cause severe negative effects, together with:
- See “What’s a very powerful info I ought to find out about isotretinoin capsules?”
- elevated stress within the mind (intracranial hypertension). Isotretinoin capsules can enhance the stress in your mind. This could result in everlasting lack of eyesight, and in uncommon instances, demise. Cease taking isotretinoin capsules and name your healthcare supplier immediately in case you get any of those indicators of elevated mind stress: unhealthy headache, blurred imaginative and prescient, dizziness, nausea or vomiting, seizures (convulsions), or stroke.
- severe pores and skin issues. Pores and skin rash can happen in sufferers taking isotretinoin capsules. Typically rash could be severe and should result in demise. Cease utilizing isotretinoin capsules and name your healthcare supplier immediately in case you get: conjunctivitis (pink or infected eyes, like “pink eye”); rash with a fever; blisters on legs, arms or face; sores in your mouth, throat, nostril or eyes; or peeling of your pores and skin.
- irritation of your pancreas (pancreatitis) can occur in sufferers who take isotretinoin capsules and might result in demise. Name your healthcare supplier immediately you probably have any of the next signs of pancreatitis: extreme higher abdomen (stomach) ache, swelling of your abdomen, nausea and vomiting, or fever.
- elevated blood fats (lipid) ranges. Isotretinoin capsules can increase blood fats ranges (ldl cholesterol and triglycerides). Your healthcare supplier will do blood exams to verify your lipids earlier than and through remedy. These issues normally go away when isotretinoin capsules remedy is completed.
- listening to issues. Cease utilizing isotretinoin capsules and name your healthcare supplier in case your listening to will get worse or you probably have ringing in your ears. Your listening to loss could also be everlasting.
- liver issues, together with hepatitis. Your healthcare supplier will do exams to verify your liver earlier than and through remedy with isotretinoin capsules. Name your healthcare supplier in case you get: yellowing of your pores and skin or the whites of your eyes, ache on the fitting facet of your abdomen space (stomach), darkish urine, bleeding or bruising extra simply than regular.
- irritation of your digestive tract (inflammatory bowel illness).Cease taking isotretinoin capsules and name your healthcare supplier in case you get: extreme abdomen, chest or bowel ache; nausea or vomiting; hassle swallowing or painful swallowing; new or worsening heartburn; diarrhea; or rectal bleeding.
- bone and muscle issues. Bone issues embody bone ache, softening or thinning (which can result in fractures). Inform your healthcare supplier in case you plan onerous bodily exercise throughout remedy with isotretinoin capsules. Inform your healthcare supplier in case you get: again ache, joint ache or muscle ache, or a damaged bone. Inform all healthcare suppliers that you simply take isotretinoin capsules in case you break a bone.
Cease isotretinoin capsules and name your healthcare supplier immediately you probably have muscle weak point. Muscle weak point with or with out ache could be a signal of significant muscle harm.
Isotretinoin capsules could cease lengthy bone progress in youngsters who’re nonetheless rising.
- imaginative and prescient issues. Cease taking isotretinoin capsules and name your healthcare supplier immediately you probably have any imaginative and prescient adjustments. Isotretinoin capsules could have an effect on your capacity to see at nighttime. This normally goes away after you cease taking isotretinoin capsules, however it might be everlasting. Some sufferers get dry eyes throughout remedy. In the event you put on contact lenses, you might have hassle carrying them throughout and after you cease remedy with isotretinoin capsules.
- severe allergic reactions. Cease taking isotretinoin capsules and get emergency medical assist immediately in case you get hives, a swollen face or mouth, or have hassle respiratory. Cease taking isotretinoin capsules and name your healthcare supplier in case you get a fever, rash, or pink patches or bruises in your legs.
- blood sugar issues, together with diabetes. Inform your healthcare supplier in case you are very thirsty or urinate greater than regular.
The most typical negative effects of isotretinoin capsules embody:
- dry lips
- dry pores and skin
- again ache
- dry eyes
- joint ache
- nostril bleeds
- higher respiratory tract an infection (frequent chilly)
- chapped lips or swelling of the lips
- pores and skin reactions
- muscle issues
- eye issues, together with decreased imaginative and prescient
These should not all the doable negative effects of isotretinoin capsules. Name your physician for medical recommendation about negative effects. You’re inspired to report negative effects of pharmaceuticals to the FDA. Go to www.fda.gov/medwatch or name 1-800-FDA-1088.
For extra info, please see accompanying full Prescribing Information. A duplicate could also be requested from Teva U.S. Medical Data at 888-TEVA-USA (888-838-2872), [email protected], or Teva’s Public Relations or Investor Relations contacts.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been creating and producing medicines to enhance folks’s lives for greater than a century. We’re a world chief in generic and specialty medicines with a portfolio consisting of over 3,500 merchandise in almost each therapeutic space. Round 200 million folks all over the world take a Teva medication each day, and are served by one of many largest and most complicated provide chains within the pharmaceutical business. Together with our established presence in generics, we’ve got vital revolutionary analysis and operations supporting our rising portfolio of specialty and biopharmaceutical merchandise. Be taught extra at www.tevapharm.com.
Cautionary Be aware Concerning Ahead-Trying Statements
This press launch incorporates forward-looking statements inside the that means of the Personal Securities Litigation Reform Act of 1995 concerning the launch of our 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg energy generic Isotretinoin oral capsules in the USA, that are primarily based on administration’s present beliefs and expectations and are topic to substantial dangers and uncertainties, each recognized and unknown, that might trigger our future outcomes, efficiency or achievements to vary considerably from that expressed or implied by such forward-looking statements. Vital components that might trigger or contribute to such variations embody dangers referring to:
- the industrial success of our 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg energy generic Isotretinoin oral capsules;
- our capacity to efficiently compete within the market, together with: that we’re considerably depending on our generic merchandise; consolidation of our buyer base and industrial alliances amongst our clients; delays in launches of latest generic merchandise; the rise within the variety of opponents concentrating on generic alternatives and in search of U.S. market exclusivity for generic variations of serious merchandise; our capacity to develop and commercialize biopharmaceutical merchandise; competitors for our specialty merchandise, together with AUSTEDO®, AJOVY® and COPAXONE®; our capacity to attain anticipated outcomes from investments in our product pipeline; our capacity to develop and commercialize extra pharmaceutical merchandise; and the effectiveness of our patents and different measures to guard our mental property rights;
- our substantial indebtedness, which can restrict our capacity to incur extra indebtedness, interact in extra transactions or make new investments, could lead to an additional downgrade of our credit score rankings; and our incapability to lift debt or borrow funds in quantities or on phrases which might be favorable to us;
- our enterprise and operations usually, together with: uncertainty concerning the magnitude, period, and geographic attain of the COVID-19 pandemic and its affect on our enterprise, monetary situation, operations, money flows, and liquidity and on the economic system usually; our capacity to efficiently execute and preserve the actions and efforts associated to the measures we’ve got taken or could absorb response to the COVID-19 pandemic and related prices therewith; effectiveness of our optimization efforts; our capacity to draw, rent and retain extremely expert personnel; manufacturing or high quality management issues; interruptions in our provide chain; disruptions of data know-how techniques; breaches of our information safety; variations in mental property legal guidelines; challenges related to conducting enterprise globally, together with political or financial instability, main hostilities or terrorism; prices and delays ensuing from the in depth pharmaceutical regulation to which we’re topic or delays in governmental processing time as a consequence of journey and work restrictions brought on by the COVID-19 pandemic; the consequences of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and protection; vital gross sales to a restricted variety of clients; our capacity to efficiently bid for appropriate acquisition targets or licensing alternatives, or to consummate and combine acquisitions; and our prospects and alternatives for progress if we promote property;
- compliance, regulatory and litigation issues, together with: failure to adjust to complicated authorized and regulatory environments; elevated authorized and regulatory motion in reference to public concern over the abuse of opioid drugs and our capacity to succeed in a remaining decision of the remaining opioid-related litigation; scrutiny from competitors and pricing authorities all over the world, together with our capacity to efficiently defend towards the U.S. Division of Justice felony fees of Sherman Act violations; potential legal responsibility for patent infringement; product legal responsibility claims; failure to adjust to complicated Medicare and Medicaid reporting and cost obligations; compliance with anti-corruption sanctions and commerce management legal guidelines; and environmental dangers;
- different monetary and financial dangers, together with: our publicity to forex fluctuations and restrictions in addition to credit score dangers; potential impairments of our intangible property; potential vital will increase in tax liabilities; and the impact on our general efficient tax charge of the termination or expiration of governmental applications or tax advantages, or of a change in our enterprise;
and different components mentioned on this press launch and in our Annual Report on Type 10-Okay for the 12 months ended December 31, 2020, together with within the sections captioned “Threat Elements” and “Ahead Trying Statements.” Ahead-looking statements communicate solely as of the date on which they’re made, and we assume no obligation to replace or revise any forward-looking statements or different info contained herein, whether or not on account of new info, future occasions or in any other case. You’re cautioned to not put undue reliance on these forward-looking statements.
1 Absorica® is a registered trademark of Solar Pharmaceutical Industries Inc.