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CMS Issues Final Aducanumab Coverage Decision
By Gina Shaw
The Centers for Medicare & Medicaid Services (CMS) finalized its Medicare coverage policy for the controversial Alzheimer’s disease drug aducanumab (Aduhelm, Biogen) on April 7, 2022. As in the initial plan released in March, aducanumab will be covered for Medicare recipients under the “coverage with evidence development” (CED) guidance, meaning the drug will only be covered in the setting of a clinical trial.
However, the final proposal contains several key changes from the original draft.
Coverage is expanded beyond the original proposal, which included only CMSapproved randomized controlled trials. Instead, Medicare will cover the drug for participants in any trial approved by the FDA or the National Institutes of Health. “The final decision allows for flexibility in a less rigorous study design for antiamyloid mAbs [monoclonal antibodies] that
have been approved by FDA through the traditional approval process for the treatment of AD,” CMS noted in a statement.
These trials are not restricted to hospital-based outpatient facilities, as in the original proposal, and can be conducted in other sites such as freestanding outpatient infusion centers and physician practices. The coverage decision does require that “any clinical study protocol submitted for CMS-approval include a description of the multidisciplinary dementia team and optimal medical management, and the study sites with clinical expertise and infrastructure to provide treatments consistent with the safety monitoring outlined in the FDA-approved label.”
People with Down syndrome and other populations who were excluded from eligibility for CED coverage in the original proposal will be eligible for trial participation and coverage under the final policy. The trials also must comply with a Medicare requirement to recruit a racially and ethnically diverse group of participants; most participants in the original EMERGE and ENGAGE trials of aducanumab were white.
Finally, any future FDA-approved mAbs targeting amyloid will not automatically be subject to the same CED policy, as proposed in the draft policy. For drugs that follow the FDA’s traditional approval pathway, patients will not need to be enrolled in a randomized trial to have the drug covered by Medicare, according to CMS; instead, they can be in a registry-based study, which does not require a placebo arm. (Drugs that go through the same accelerated approval pathway as aducanumab will be subject to the same clinical trial requirements.)
“CMS wants to support the development of and access to innovative therapies that provide reasonable and necessary treatments to Medicare patients,” said Tamara Syrek Jensen, JD, Director of the Coverage and Analysis Group in the Centers for Clinical Standards and Quality at CMS, in a public call with stakeholders on April 11, 2022, explaining the rationale behind the two coverage pathways. “The second pathway allows for a wider array of studies for drugs that receive traditional approval, such as data collection in a registry.”
Ms. Jensen added that the approach was “tailored to drugs in this class” and would not affect CMS’ decisionmaking about other drugs approved via the FDA’s accelerated approval pathway. “This is an evolving area and we intend to be nimble and flexible as new evidence is developed,” she said. “We can reconsider our coverage with evidence development decisions, and have done so in the past when appropriate.”
“This unprecedented CMS decision effectively denies all Medicare benefi-
ciaries access to Aduhelm,” Biogen said in a statement. “These coverage restrictions, including the distinction between accelerated approval and traditional approval, have never been applied to FDA-approved medicines for other disease areas.”
Caleb Alexander, MD, a professor of epidemiology and medicine at Johns Hopkins Bloomberg School of Public Health and the co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, in Baltimore, told Pharmacy Practice News that CMS had threaded the needle fairly well under difficult circumstances. “Under extraordinary pressure from many different sides, they have made an evidencebased decision that doesn’t abandon the notion that we need to understand if drugs are safe and effective before they’re used and covered, and that’s exactly what we need for a question that is as important as this one to get right,” said Dr. Alexander, who serves on the FDA’s Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee, which recommended in November 2020 that the agency not approve aducanumab. “They will evaluate the next products on their own merits, which will obviously require more work on the part of CMS, but it’s the right decision. There may be important differences in how these products work, as well as in the totality of evidence regarding their safety and effectiveness. This approval was highly atypical in many ways, and I think the FDA is unlikely to approve another product based on evidence that is as flimsy as this was.”
Lee Fleisher, MD, the chief medical officer and director of CMS’ Center for Standards and Quality, underscored the importance of remembering the original scope of aducanumab’s approval. The drug “was approved for mild cognitive impairment, meaning that it is directed at patients who are recently healthy and may not have outward signs of dementia,” he said during the stakeholder call. “There may be potential for promise
with this treatment; however, while it is known to reduce amyloid plaques in the brain, there is not currently evidence that this leads to clinical benefit in the form of improved cognitive function. Meanwhile, the known risks include potentially fatal brain bleeds. Taken together, there is not yet sufficient evidence to support coverage of this drug for people with Medicare until the statutory ‘reasonable and necessary’ standard is met.”
A History of Concern
Although patient advocacy groups have been lobbying for a more favorable aducanumab coverage determination, several managed care and provider stakeholders have long been on record urging far more restraint.
In July 2021, for example, at least three major hospital systems—Cleveland Clinic in Ohio, Mount Sinai Health System in New York, and Providence Health in Washington state—announced they will not provide aducanumab, although affiliated physicians could, at least in theory, prescribe it for their patients to receive it elsewhere. At the time, the Neurology Center, a leading independent neurology group with seven locations in Washington, D.C., and Maryland, also announced that it would not be providing aducanumab.
Pushback also has come from several commercial plans, with several announcing that they will not cover aducanumab, including Blue Cross Blue Shield affiliates in Florida, Kansas, New York, Michigan, North Carolina and Pennsylvania. Policies posted online indicated that these payors were denying coverage because they considered the drug “investigational” or “experimental” or because “a clinical benefit has not been established.”
—Caleb Alexander, MD
PAYMENT TRENDS
continued from page 23
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Wholesale offerings. In a virtual satellite symposium at the 2021 ASHP Midyear Clinical Meeting and Exhibition, AmerisourceBergen described four ways to achieve financial sustainability, including prescription internalization and value-based contract outcomes (bit.ly/ 3vsrPG2). Cardinal Health offered its own take on innovative payment strategies with several programs. The company’s Reimbursement Solution program helps reduce patients’ rejected claims and helps connect patients to available financial assistance. Cardinal Health Specialty group purchasing organizations (GPOs) help qualifying health-system outpatient facilities access the most cost-effective pricing available for qualifying specialty, brand-name and biosimilar limited distribution drugs. The new Cardinal Health Traverse GPO provides qualified, non-340B outpatient facilities access to health-system class-of-trade pricing across oncology, urology, rheumatology, nephrology, ophthalmology, gastroenterology, neurology, allergy and asthma.
PBMs: old and new. Rising list prices are being linked to rising rebates from PBMs, with three major PBMs—CVS Caremark, Express Scripts and OptumRx—controlling nearly 80% of U.S. prescription benefit transactions. PBMs have been criticized for profiting from rebates and discounts and failing to pass on an estimated $120 billion back to consumers, as noted in an amicus brief advocating for more state regulation of PBMs posted on the Community Oncology Alliance website (bit.ly/3uTQJza).
New entrants into the PBM space promise to take a different approach, including EmsanaRx, a nonprofit venture owned by the Purchaser Business Group on Health; CostPlus PBM, a startup funded by Mr. Cuban; Prescryptive Health, a blockchain-powered prescription data platform; and CapitalRx, which claims that it is “on a mission to change the way prescriptions are priced and administered to create enduring social change.”
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Hospitals and physician offices charged patients significantly higher amounts for drugs than specialty pharmacies, according to a new study by AHIP, a national association representing health insurance providers (bit. ly/3Mk7CZG). Researchers analyzed costs of 10 drugs between 2018 and 2020 that healthcare settings—including hospitals—purchased, stored and administered, and examined how specialty pharmacies could safely and securely deliver those medications for provider administration. Medications administered by hospitals cost an average of $7,000 more than those delivered by specialty pharmacies—on average double the price. Drugs dispensed in physician offices cost an average of $1,400 more than specialty pharmacy-derived medications, for an average increase of 22%. Why the upcharge? Both hospitals and physician offices charge additional fees to administer the drugs, according to the researchers.
Another key development: The pandemic pause on sequestration’s -2% payment cuts has ended! On April 1, 2022, the cuts resumed at -1%, and on July 1, they will resume at -2%. ■
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A Patient Safety Defeat
continued from page 1
strong safety culture within our healthcare organizations, and this verdict represents a real setback. Right after the verdict, I received a number of emails from our nursing leadership expressing concern about the impact that this [guilty verdict] would have on the nursing profession.”
Michael R. Cohen, RPh, MS, the president emeritus and founder of the Institute for Safe Medication Practices (ISMP), also criticized the verdict. “When RaDonda Vaught was convicted, the entire healthcare community lost as well,” he said. “Her conviction, which made a scapegoat of one individual instead of focusing on fixing larger, preventable systemic issues, will have serious consequences for patient safety. It could hinder the reporting of errors so that we are not able to learn from them and prevent future mistakes.”
He added that the verdict also could “exacerbate the current shortage of healthcare providers by driving them away from clinical practice. If nurses believe that society, their community, and the judicial system holds them to a standard of perfection, why would they want to work in healthcare?”
On March 25, 2022, Ms. Vaught was convicted of negligent homicide in the 2017 death of 75-year-old Charlene Murphey, and is set to be sentenced on May 13. She faces up to eight years in prison. The circumstances that led to Ms. Murphey’s death sounded hauntingly familiar to many nurses, pharmacists and others involved in patient safety.
Ms. Murphey was being transferred from the neuro-ICU to a step-down unit after being diagnosed with an intraparenchymal hemorrhage. Her physician had ordered a PET scan, and Ms. Murphey asked for something to help her relax during the scan, as she was claustrophobic. The physician ordered a one-time 1-mg dose of 1 mg IV midazolam, writing the order for the brand name Versed. (Although practitioners still commonly use that name, ISMP noted that the Versed brand has been discontinued in the United States for some time). Both the patient’s primary nurse and a radiology nurse were unavailable to administer the medication, so Ms. Vaught, a “help-all” (floater) nurse, was summoned.
At the neuro-ICU’s automated dispensing cabinet (ADC), Ms. Vaught entered the first two letters of the drug’s brand name, “VE,” into the search field but received no results, because the ADC’s default setting was generic drug names. She then initiated an override setting, searched for VE again and selected the first medication in the results, the neuromuscular blocker vecuronium. A red box warning noted that the medication should be associated with a STAT order, but the ADC nonetheless opened and allowed the nurse to retrieve the medication.
Ms. Vaught missed several red flags, including the drug name on the front of the vial label, the fact that Versed is only available as an injectable liquid while the vecuronium she drew up was a powder requiring reconstitution, and the warning label on the red vecuronium vial ferrule that said, “WARNING: PARALYZING AGENT.” (That label has been overlooked or misunderstood in other paralyzing agent errors, ISMP reported.)
After administering what she thought to be Versed, Ms. Vaught left Ms. Murphey in the radiology holding area and went to the emergency department; she had been on her way there to conduct a swallowing study before being called in for this task. When the patient was found unresponsive by a transport technician about 30 minutes later, a code blue was called. Although she was resuscitated, her condition worsened and she died the next day after being withdrawn from life support.
Ms. Vaught immediately responded when the code team was called, reporting to the physicians her belief that she had administered IV Versed. She gave the bag containing the empty vial and syringes with leftover drug to the patient’s primary nurse, who discovered the error. It was disclosed to the patient’s family—with whom Vanderbilt later reached a confidential settlement—but neither reported to state/federal officials nor the Joint Commission until an anonymous “tipster” registered a complaint with a state agency in October 2018.
At Ms. Vaught’s trial, Tennessee Bureau of Investigation officer Ramona Smith, who was testifying for the prosecution, stated that her criminal investigation focused only on Ms. Vaught’s error and not on Vanderbilt’s actions or systems. “The investigation and prosecution put everything on RaDonda, that she didn’t do this and she didn’t do that,” Mr. Cohen said. “But that ameliorates the hospital’s role in setting their systems up so that something like this won’t happen.” (Vanderbilt declined a request for comment from Pharmacy Practice News.)
“Many state health profession boards are ill-equipped to deal with the science of safety and the concept of human-based errors,” agreed Dan Degnan, PharmD, associate director, professional skills laboratory and senior project manager of the Purdue Center for Medication Safety Advancement, in West Lafayette, Ind. “Instead of holding a healthcare organization to rigorous system improvement methods, there is a focus on the human performance within flawed systems.”
Overrides Are Common
As for specific systems improvement lessons that can be learned from the Vaught case, one obvious starting point is to probe how overrides are managed. In a July 2021 hearing that ultimately led to the revocation of her license, Ms. Vaught testified before the Tennessee Board of Nursing that overrides such as the one she performed were common at the institution, and that a 2017 upgrade to the hospital’s electronic health record had caused such frequent delays that nurses were instructed to use overrides to circumvent those delays. Another nurse corroborated that testimony at the trial.
“The reason why overrides exist is that there are certain medications for which the time for a pharmacist to review an order may take longer than the time that is needed to get the medication to a patient, such that the delay itself can cause a safety risk,” the University of Chicago Medicine’s Dr. Hope said. “It’s standard practice in all hospitals to maintain an override list, but these lists can sometimes get very long or become abused. One of the things that ISMP, the Joint Commission and other
6 Paralytic Error Prevention Strategies
The Institute for Safe Medication Practices (ISMP) recommended several systems-based approaches to reduce the risk for medication errors involving sedation and paralytics in the wake of the RaDonda Vaught case. Here, we highlight 6 of the strategies. (For more details, access an ISMP article on the strategies at bit.ly/3EOH8Nn.)
1Establish a standard process for patients who require sedation before radiology procedures that starts with an oral antianxiety medication and includes patient monitoring requirements.
2Include IV moderate sedation agents such as IV midazolam on high-alert medication lists, with specified monitoring requirements, including a means of evaluating the adequacy of ventilation.
3Eliminate storage of neuromuscular blockers outside of areas where they are not routinely needed. Outside perioperative areas (e.g., critical care or the emergency department), store these agents in a sealed box or rapid sequence intubation kit. If vials must be stored in automated dispensing cabinets (ADCs), place them in locked-lidded pockets with auxiliary warning labels stating, for example, “WARNING: CAUSES RESPIRATORY ARREST—PATIENT MUST BE VENTILATED.” Warnings should be visible when ADC pockets, drawers or lids are open.
4Require a witness upon removal of certain medications on override.
5Implement barcode scanning verification in all areas.
6Teach practitioners how to toggle between brandname and generic search functions if they are separate, and to verify the drug search criteria if initially unable to find the desired medication, rather than triggering an override. At RaDonda Vaught’s trial, the prosecution emphasized her failure to heed the warning label on top of the vial that clearly stated the drug was a paralytic. But medication safety experts note that these vial-cap warnings are not fail-safe, since the caps are not seen or are quickly removed and discarded when a “stat” drug is being prepared for administration.
agencies have stressed with pharmacy departments over the years is to evaluate that list carefully. Does this medication truly warrant being on the list? Is this an antidote? Is it for a critical patient? Will there be a physician at the bedside? There need to be criteria such as these to decide if a drug goes on override or not.” That said, a paralytic agent would legitimately be on the override list, Dr. Hope noted. “If you have a patient crashing at the bedside and the anesthesiologist needs to administer the paralytic to intubate and put the patient onto a respirator, you want that done fairly quickly. But to avoid errors such as the one that happened here, we have added an alert for paralytics that specifically asks if the patient is intubated or about to be intubated. That’s not just a pop-up warning— you have to answer it with a yes or no.”
Labeling of Paralytics
At Ms. Vaught’s trial, there was much emphasis on her failure to note the label on top of the vial that clearly stated the drug was a paralytic. But Dr. Hope observed that this ignores how most healthcare providers work with such vials. “The first thing we do is pop the cap,” she said. “That’s the first thing that gets removed and is in the garbage. No one is reading the cap. Labeling needs to be designed on these products such that they help to mitigate those errors that occur because we are human, we are rushing and we are distracted—all those things that can happen in a complex healthcare system.”
One possible solution, she observed, might be shrink-wrapping around the entire vial for paralytic agents, possibly with a bright yellow color and stripe that says “PARALYTIC.” “That might take a little extra effort to open, but that’s the point: to slow you down for a second to realize what this is,” she said. “At our institution, after this incident happened, we went and reviewed our Omnicell data to run reports on how often paralytics are being pulled out on override and who is doing it, and providing that feedback as part of our surveillance of safety practices.”
ISMP agrees that shrink-wrapping could be a potential fix—but with a caveat. “Be aware that the use of a shrink wrap sleeve … on different neuromuscular blockers can make them look similar and contribute to mix-ups. Limiting the variety of neuromuscular blockers available in ADCs can help reduce similar appearance,” ISMP reported in a 2019 article on strategies for preventing errors with neuromuscular blocking agents (sidebar).
The 2-Letter Shortcut
Stocking and dispensing from ADCs have become much more systematized and safety-focused over the past several years, Mr. Cohen said, but the potential for errors remains. “In this case, we saw that you can type in two letters and get a drug that could kill someone, if used incorrectly. And if you don’t have a way to barcode scan that vial against what is on the patient’s list of medications, or you are doing this on override, then you are in jeopardy of possibly preparing and giving the wrong thing,” he noted. “We have asked Pyxis and Omnicell, the two vendors used by most institutions, if they can make software modifications available so that if you’re removing something on override, you need to type in at least five letters rather than just two. If that solution had been in place here, she never would have gotten vecuronium on the list. I know that at least Omnicell has made that modification available, and understand that BD Pyxis will be doing this as well.”
While awaiting the verdict, Ms. Vaught told the Tennessean that she had “zero regrets about telling the truth.” But Mr. Cohen predicted that the “just culture” model may well take a hit. “Mistakes that did not lead to a serious outcome, near misses—those are the kinds of things I do think may not get reported as they have been in the past, because people don’t want to put themselves in a position of getting punished by internal management, nursing boards, or as in this case, something criminal. But we implore people to continue to report, because the learning has to be there and our hospital organizations have to understand how important it is to truly follow the just culture model.”
The sources reported no relevant financial disclosures.
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Brief Summary of Prescribing Information These highlights do not include all the information needed to use CLINOLIPID safely and effectively. See full prescribing information for CLINOLIPID. CLINOLIPID (lipid injectable emulsion), for intravenous use.
Initial U.S. Approval: 1975
WARNING: DEATH IN PRETERM INFANTS
• Deaths in preterm infants have been reported in literature. • Autopsy findings included intravascular fat accumulation in the lungs. • Preterm and low birth weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.
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CLINOLIPID is indicated in adults for providing a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Limitations of Use: • CLINOLIPID is not indicated for use in pediatric patients because there is insufficient data to demonstrate that CLINOLIPID provides sufficient amounts of essential fatty acids in this population. • The omega-3: omega-6 fatty acid ratio in CLINOLIPID has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions.
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• When admixing CLINOLIPID, protect the admixed parenteral nutrition solution from light. Use only a 1.2 micron in-line filter to administer CLINOLIPID and admixtures containing CLINOLIPID. • See full prescribing information for administration and admixing instructions. • CLINOLIPID is intended for intravenous infusion. • The recommended dose depends on energy expenditure, clinical status, body weight, tolerance, ability to metabolize and consideration of additional energy given to patient. The usual daily lipid dosage in adults is 1 to 1.5 g/kg/day and should not exceed 2.5 g/kg/day.
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CLINOLIPID 20% is a lipid injectable emulsion. The lipid content is 0.2 grams/mL in 100 mL, 250 mL, 500 mL, and 1000 mL.
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• Known hypersensitivity to egg and soybean or to any of the ingredients, including excipients. • Severe hyperlipidemia or severe disorders of lipid metabolism.
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1. Granato D, et al. JPEN J Parenter Enteral Nutr, 2000;24:113-8 2. Buenestado, et al. JPEN J Parenter Enteral Nutr 2006;30:286-296. 3. Olthof ED, et al. Clin Nutr. 2013;32(4):643-649. 4. Reimund JM, et al. Clin Nutr 2004;23:1324-32. 5. Clinolipid (Lipid Injectable Emulsion, USP) 20% for intravenous use PI, 2021.
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The most common (5%) adverse drug reactions from clinical trials were nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia and abnormal liver function tests.
To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch DRUG INTERACTIONS
The anticoagulant activity of coumarin derivatives, including warfarin, may be counteracted.
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Hepatic Impaired: Use with caution in patients with preexisting liver disease or liver insufficiency.
Please visit www.baxterpi.com for Full Prescribing Information
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