Your first 90 days
Your first 90 days on Palsonify for acromegaly
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Palsonify has no REMS form, no vaccine and no test result the pharmacy must see before it ships. The label does ask for blood sugar checks at the start and at each dose change, and an IGF-1 test decides the step to 60mg. Daily life on it is shaped by timing, a pill on an empty stomach with a wait before eating. This page lays out the first 3 months from the FDA label, the CrinetiCARE program and one insurer's written rules.
What has to happen before the first bottle ships
Palsonify is a specialty drug without a REMS, so the first fill waits on the insurance approval and a specialty pharmacy, not on a safety program form. These are the 7 things in the way, in order.
Your IGF-1 history, for the insurer
Cigna's policy wants an IGF-1 level above the normal range from before any acromegaly medicine was started.
- It also wants a note that surgery or radiation did not work well enough or is not an option.
- Ask the office whether these results are already in your chart.Cigna policy
If you take octreotide or lanreotide injections now
The label does not say how to time a switch from injections.
- In the PATHFNDR-1 trial, people took their first Palsonify dose when their next injection would have been due.
- Your endocrinologist decides the timing for you.PATHFNDR-1 paper
A medicine review
Heartburn medicines called proton pump inhibitors lower Palsonify levels, and so do medicines that speed up the liver enzyme CYP3A4.
- The Patient Information also asks you to name any medicine that slows the heart rate.
- Bring a full list, including vitamins and herbal supplements.FDA label
Gallbladder, blood sugar and heart rate history
The Patient Information asks you to tell your provider about gallbladder problems, blood sugar control problems and a low heart rate.
- If you take diabetes medicines, the label says those may need adjusting once Palsonify starts.FDA label
Pregnancy and breastfeeding, raised before day 1
The label says it is not known whether Palsonify harms an unborn baby or passes into breast milk.
- It sets no pregnancy test or birth control requirement.
- Tell the endocrinologist if you are pregnant, planning a pregnancy or breastfeeding.FDA label
CrinetiCARE enrollment and the insurance approval
The office faxes the enrollment form to CrinetiCARE at 844-276-3299, with copies of both sides of your insurance card.
- You sign a consent page, and CrinetiCARE can collect your signature later if you are not in the office.
- The form lets CrinetiCARE verify benefits and help with the prior authorization.Enrollment form
A specialty pharmacy ships it
Palsonify comes from Biologics by McKesson (800-850-4306), Orsini Specialty Pharmacy (847-239-5680) or select pituitary centers.
- These pharmacies ship it to your home and help confirm your insurance coverage.CrinetiCARE
The days that matter
Counted from the first dose, with the IGF-1 check that decides the 60mg step, the blood sugar checks at each dose change, and refills every 30 days. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.Enrollment form and the insurance request
The office sends the CrinetiCARE enrollment form, and CrinetiCARE checks your benefits and sends the form to an in-network specialty pharmacy.
- The pharmacy or CrinetiCARE helps start the prior authorization, which the office submits.
If approval is slow, a quick start supply
Crinetics may supply Palsonify free while coverage is pending or under appeal.
- Insured patients qualify after a documented delay of at least 48 hours once the insurer has everything it needs.
First dose, two 20mg tablets with water
The starting dose of 40mg is two 20mg tablets taken together once a day, on an empty stomach after at least 6 hours without food.
- Nothing but water for at least 1 hour afterward.
- Crinetics gives the example of taking it before breakfast.
IGF-1 test and the 60mg question
The label says that after 2 to 4 weeks on 40mg, the dose is raised to 60mg based on IGF-1 levels.
- It also says blood sugar is checked whenever the dose changes.
A new strength means a new bottle
The 60mg dose is two 30mg tablets once a day, a different tablet from the 20mg starting tablet.
- That means a new prescription and a new bottle from the specialty pharmacy.
Refill, then about every 30 days
Each bottle holds 60 tablets, which lasts 30 days at 2 tablets a day.
- A temporary drop to 20mg, one tablet a day, makes a bottle last longer, so check the count with the pharmacy.
Stomach side effects and heart rate
In the 2 placebo-controlled trials, most stomach side effects began in the first 2 months and lasted a median of 6 to 18 days.
- A slow heart rate, when it happened there, appeared within the first 3 months and caused no symptoms.
Refill, number 2
Three months in
The label recommends periodic thyroid tests and periodic monitoring for gallstones, with no fixed schedule.
- In the trials, most gallstone problems happened within the first 9 months.
- Your endocrinologist sets the timing.
Refill, number 3
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Palsonify label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Current label dated September 16, 2025, read from the FDA's label database today. FDA label
- September 2025
The FDA approved Palsonify on September 25th for adults with acromegaly who had an inadequate response to surgery or cannot have surgery. The FDA asked Crinetics to report retinal and other eye findings quickly for 5 years. The label has not been revised since.FDA letter
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- Once a day, on an empty stomach
The label says to take Palsonify with water at least 6 hours after a meal and at least 1 hour before the next meal.
- Food cuts absorption sharply.
- In a study, a low-fat meal lowered the amount absorbed by 72%, and a high-fat meal by 85%.FDA label
- Only water during the hour after
Crinetics says to wait at least 1 hour before eating or drinking anything other than water.
- It also suggests taking Palsonify at the same time every day.Taking Palsonify
- The tablets and a temporary lower dose
The pink tablets are 20mg and the yellow tablets are 30mg.
- During the start, the label allows a temporary drop to 20mg for side effects, then a return to 40mg once they settle.FDA label
- If you miss a dose
Neither the label nor the Patient Information gives an instruction for a missed dose.
- The Patient Information says to take Palsonify exactly as your healthcare provider tells you.
- Ask the pharmacist or endocrinologist what to do before it happens.FDA label
- Heartburn medicines
Proton pump inhibitors lowered Palsonify levels by 21% at a 20mg dose and 42% at 60mg.
- The label says they may call for a higher Palsonify dose.
- It says people already on 60mg should avoid them.FDA label
- Medicines that speed up CYP3A4
Strong or moderate CYP3A4 inducers, such as carbamazepine and efavirenz, lower Palsonify levels.
- The label lets the prescriber raise the Palsonify dose, with a ceiling of 120mg a day.FDA label
- Heart rate and other medicines
Palsonify can slow the heart rate.
- The label says doses of other heart-slowing medicines, such as beta-blockers, may need adjusting.
- It also lowers cyclosporine levels, so cyclosporine blood levels are followed.FDA label
- Storage
Room temperature, 68 to 77 degrees Fahrenheit (20 to 25 Celsius), in the original container.
- The Patient Information says to keep it out of the reach of children.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
Gallbladder problems
Tell your healthcare provider about sudden pain in the upper right belly, the right shoulder or between the shoulder blades.
- Yellow skin or eyes and pale stools count too.
- In the trials, 6% of people had gallstones or a related problem.FDA label
High or low blood sugar
Blood sugar rose on Palsonify in the first trial.
- A few people, most of them on diabetes medicines, had low blood sugar.
- The Patient Information says to tell your provider about either problem.FDA label
A heartbeat that is not normal
The Patient Information says to tell your provider if your heart is not beating normally.
- In the first trial, 7% of people on Palsonify had a slow heart rate, against none on placebo.FDA label
Fatty or loose stools
New fatty stools, a change in stool color, loose stools, bloating or weight loss can mean fat is not being absorbed.
- The label says the provider then checks whether the pancreas is making enough digestive enzymes.FDA label
Diarrhea, belly pain and nausea
In the first trial, diarrhea affected 33% of people on Palsonify against 14% on placebo.
- Most stomach side effects began in the first 2 months and lasted a median of 6 to 18 days.FDA label
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- The plan wants an injection tried firstCigna covers Palsonify only after one of octreotide LAR (Sandostatin LAR Depot or its generic), Somatuline Depot or lanreotide injection has been tried. The office lists which injection you used on the request.Cigna policy
- Missing IGF-1 or surgery historyCigna wants an IGF-1 above the normal range from before any acromegaly medicine, plus a note on surgery or radiation. The prescriber must be an endocrinologist or work with one.Cigna policy
- Prior authorization deniedCrinetiCARE helps offices with benefits checks, prior authorization and appeals. Its site gives the office a letter of medical necessity template and an appeal letter template.CrinetiCARE HCP
- More tablets than the plan allowsCrinetics warns that plans may cap the tablets allowed per day. It tells offices to state the target dose, since both 40mg and 60mg are 2 tablets a day.Access guide
- Coverage is taking a whileThe Quick Start and Bridge Program may supply Palsonify free while coverage is pending or under appeal. Insured patients qualify after a documented delay of at least 48 hours once the insurer has all it needs.CrinetiCARE terms
- A copay you cannot payCrinetics' guide for offices says commercially insured patients may pay as little as $0, with up to $25,000 in support a year. People covered by federal or government-funded programs are excluded from the copay program.Access guide
- Your plan uses a copay maximizer or accumulatorThe copay card terms say patients whose plan runs either program are not eligible to use the card. Call CrinetiCARE to ask what other help may apply.CrinetiCARE terms
Cigna prior authorization policy, September 1, 2026
- Age 18 or older, with acromegaly
- Surgery or radiation did not work well enough, is not appropriate, or the tumor's size is causing harm such as pressure on the optic nerve
- An IGF-1 level above the normal range for age and sex, measured before any somatostatin analog, dopamine agonist or Somavert was started
- Prescribed by, or in consultation with, an endocrinologist
- In Employer Plans and Individual and Family Plans, one of octreotide LAR, Somatuline Depot or lanreotide injection tried first
Approval length. A year at a time.
Cigna first made this policy effective on January 15, 2026, and its August 13, 2026 review made no criteria changes. It cites the September 2025 label, which is still the current label. Other plans set their own rules. The Blue Cross Blue Shield Federal Employee Program, for one, has no injection-first step. It asks the prescriber to agree to monitor IGF-1, blood sugar, thyroid function, ECG, vitamin B12 and gallstone signs, and allows up to 120mg a day for 12 months. It is here as an example of what a plan asks for, not as a rule. Cigna policy
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- One-on-one nurse educators for ongoing support and education during treatment
- Help navigating insurance coverage and finding a specialist near you
- A copay program for commercial insurance, as little as $0, with 12 months of enrollment and no income requirement, not for people covered by state or federal healthcare programs
- A quick start supply so you can begin therapy while insurance coverage is being decided
- A patient assistance program giving Palsonify at no cost to eligible people who are uninsured or whose insurance excludes it, including people on Medicare or Medicaid
- Links to independent foundations, including The Assistance Fund, PAN Foundation, HealthWell Foundation and Patient Advocate Foundation
Details as the drugmaker publishes them. CrinetiCARE
Five questions for the pharmacist or the support line
- Are you Biologics by McKesson or Orsini, and what number will your calls come from?
- If my dose goes up to 60mg, how do I get the 30mg bottle, and what happens to my leftover 20mg tablets?
- I take these medicines. Is any of them a proton pump inhibitor, a CYP3A4 inducer or a medicine that slows the heart?
- What should I do if I miss a dose, since the label does not say?
- When should I order my refill so I do not run out before the 30 days end?
Questions people ask in the first weeks
Can I take Palsonify with breakfast?
No. The label says to take it with water at least 6 hours after a meal and at least 1 hour before the next one. In a study, even a low-fat meal cut the amount absorbed by 72%.
How do I switch from octreotide or lanreotide injections to Palsonify?
The label does not give switching instructions. In the PATHFNDR-1 trial, people took their first dose when their next injection would have been due, and 83% kept a normal IGF-1 at week 36 against 4% on placebo. Your endocrinologist decides the timing.
What tests will I need on Palsonify?
The label says blood sugar is checked at the start and at each dose change, and IGF-1 guides the step to 60mg. It recommends periodic thyroid tests and periodic monitoring for gallstones. Vitamin B12 may be checked if your provider thinks it is needed.
Can I keep taking my heartburn medicine with Palsonify?
The label says proton pump inhibitors lower Palsonify levels and may call for a higher dose. It says people already on 60mg should avoid them. Your endocrinologist decides how to handle it.
How long does it take to get Palsonify after it is prescribed?
There is no fixed number of days. There is no REMS and no test result the pharmacy must see before it ships, so the wait is mostly the insurance approval. If that is delayed, the Quick Start program may supply it free.
Does Medicare cover Palsonify?
The CrinetiCARE copay card is closed to Medicare patients by its terms. The patient assistance program can supply it free to eligible people whose insurance excludes it, including Medicare. Crinetics' Medicare guide notes that Part D out-of-pocket costs for covered drugs are capped at $2,100 in 2026.
Who makes Palsonify now?
Crinetics Pharmaceuticals developed it, and Vertex Pharmaceuticals completed its purchase of Crinetics on September 1, 2026. The CrinetiCARE pages still list Crinetics and the same phone numbers as of November 7, 2026.
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Sources
- DailyMed - PALSONIFY- paltusotine tablet, film coated (prescribing information and Patient Information, revised September 2025), Crinetics Pharmaceuticals, via DailyMed, September 16, 2025.
- PALSONIFY prescribing information, September 2025 (Drugs@FDA file 219070s000lbl.pdf), FDA, Drugs@FDA, September 25, 2025.
- NDA 219070 approval letter, Palsonify (paltusotine) tablets, September 25, 2025, FDA, September 25, 2025.
- Approved Risk Evaluation and Mitigation Strategies (REMS), FDA, November 7, 2026.
- CrinetiCARE: PALSONIFY™ Patient Assistance Program, Crinetics Pharmaceuticals, November 7, 2026.
- CrinetiCARE for Healthcare Professionals: PALSONIFY™ - Crineticare, Crinetics Pharmaceuticals, November 7, 2026.
- Terms and Conditions - Crineticare, Crinetics Pharmaceuticals, November 7, 2026.
- PALSONIFY Product Enrollment Form (US-PAL-26-0144-2), Crinetics Pharmaceuticals, November 7, 2026.
- Access and reimbursement guide for healthcare providers (HCPs) (US-PAL-2500084-1), Crinetics Pharmaceuticals, November 7, 2026.
- Medicare coverage: A simple guide to understanding Medicare plans and Medicare Part D prescription coverage (US-PAL-2500086-1), Crinetics Pharmaceuticals, November 7, 2026.
- How To Take PALSONIFY™ (paltusotine) for Acromegaly Treatment, Crinetics Pharmaceuticals, November 7, 2026.
- MOA and Dosing for PALSONIFY™ (paltusotine) | HCP, Crinetics Pharmaceuticals, November 7, 2026.
- Acromegaly Disease Control Maintained After Switching From Injected Somatostatin Receptor Ligands to Oral Paltusotine, The Journal of Clinical Endocrinology & Metabolism, January 1, 2025.
- Somatostatin Receptor Agonist – Palsonify, Drug Coverage Policy IP0769, Cigna, September 1, 2026.
- Pharmacy Policy 5.30.099, Palsonify, Blue Cross Blue Shield Federal Employee Program, April 1, 2026.
- Vertex Completes Acquisition of Crinetics Pharmaceuticals and Announces Expansion of Executive Leadership Team, Vertex Pharmaceuticals, September 1, 2026.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing endocrinologist. Found an error? Use the report link in the footer and it will be checked against the source.