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Guide
Drug Safety-related Labeling Changes (SrLC) Database
| ANDA | Abbreviated New Drug Application |
| BLA | Biologics License Application |
| CDER | Center for Drug Evaluation and Research |
| MG | Medication Guide |
| NDA | New Drug Application |
| PCI | Patient Counseling Information |
| PI | Patient Information |
| PLR | Physician Labeling Rule |
| PLLR | Pregnancy and Lactation Labeling Rule |
| Italics | For the most part, italics indicate an FDA comment such as:
Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section. |
| Underlines | Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text. |
Sections
| BW | Box Warning |
| WP | Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format) |
| AR | Adverse Reactions (in pre-PLR format, this may be a subheading under precautions). |
| DI | Drug Interactions (in pre-PLR format, this may be a subheading under precautions). |
| USP | Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format. |
| PCI/PI/MG | Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. |
Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.
Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.
ALTOPREV (NDA-021316)
(LOVASTATIN)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
03/14/2024 (SUPPL-37)
4 Contraindications
Additions and/or
revisions underlined:
Altoprev is contraindicated in the following conditions:
Concomitant administration of strong CYP3A inhibitors and erythromycin [see Drug Interactions (7.1)].
Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3)].
Hypersensitivity to lovastatin or any excipients in Altoprev. Hypersensitivity reactions, including anaphylaxis, angioedema and Stevens-Johnson syndrome, have been reported [see Adverse Reactions (6.2)].
5 Warnings and Precautions
5.1 Myopathy and Rhabdomyolysis
Subsection title revised
Additions and/or
revisions underlined:
Altoprev
may cause myopathy and rhabdomyolysis. Acute kidney injury secondary to
myoglobinuria and rare fatalities have occurred as a result
of rhabdomyolysis with statins,
including Altoprev.
Risk Factors for Myopathy
Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs (including other lipid-lowering therapies), and higher Altoprev dosage [see Drug Interactions (7.1)].
Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis
The concomitant use of strong CYP3A4 inhibitors with Altoprev is contraindicated. If short-term treatment with strong CYP3A4 inhibitors is required, temporarily suspend Altoprev during the duration of strong CYP3A4 inhibitor treatment. The concomitant use of Altoprev with gemfibrozil or cyclosporine is not recommended [see Contraindications (4) and Drug Interactions (7.1)].
Altoprev dosage modifications are recommended for patients taking amiodarone, danazol, diltiazem, dronedarone, and verapamil [see Dosage and Administration (2.4) and Drug Interactions (7.1)].
Lipid modifying doses (>1 gram/day) of niacin, fibrates, colchicine, and ranolazine may also increase the risk of myopathy and rhabdomyolysis [see Drug Interactions (7.1)].
Use of grapefruit juice is not recommended when taking Altoprev [see Drug Interactions (7.1)].
Discontinue Altoprev if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Muscle symptoms and CK elevations may resolve if Altoprev is discontinued.
Temporarily discontinue Altoprev in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis (e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy).
Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the Altoprev dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
5.2 Immune-Mediated Necrotizing Myopathy
Additions and/or revisions underlined:
There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use, including reports of recurrence when the same or a different statin was administered. IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase that persist despite discontinuation of statin treatment; positive anti-HMGCoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. Additional neuromuscular and serologic testing may be necessary. Treatment with immunosuppressive agents may be required. Discontinue Altoprev if IMNM is suspected.
5.3 Hepatic Dysfunction
Subsection title
revised
Additions and/or revisions underlined:
Increases in serum transaminases have occurred with Altoprev [see Adverse
Reactions (6.1)]. In most cases, these changes appeared
soon after initiation, were transient, were not accompanied by symptoms, and
resolved or improved on continued therapy or after a brief interruption in
therapy. Persistent increases
to more than three times the upper
limit of normal
(ULN) in serum transaminases have occurred
in approximately 1.9% of patients receiving Altoprev in
clinical studies. Marked persistent increases of hepatic transaminases have
also occurred with Altoprev. There have been rare post marketing reports
of fatal and non-fatal hepatic failure in patients taking statins, including Altoprev.
Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury.
Consider liver enzyme testing before Altoprev initiation and when clinically indicated thereafter. Altoprev is contraindicated in patients with acute liver failure or decompensated cirrhosis [see Contraindications (4)]. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue Altoprev.
5.4
Increases in HbA1c and Fasting Serum Glucose Levels
Subsection title revised
Additions and/or revisions underlined:
Increases in HbA1c and fasting serum
glucose levels have been reported
with statins, including Altoprev. Optimize lifestyle
measures, including regular exercise, maintaining a healthy body weight,
and making healthy food choices.
6 Adverse Reactions
Additions and/or
revisions underlined:
The following
serious adverse reactions
are discussed in greater detail
in other sections
of the label:
Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1)]
Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2)]
Hepatic Dysfunction [see Warnings and Precautions (5.3)]
Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4)]
6.1 Clinical Trials Experience
Changes to table 2; please refer to label for complete information
Additions and/or
revisions underlined:
Because
clinical trials are conducted under widely varying conditions, adverse reaction
rates observed in the clinical trials
of a drug cannot be directly compared
to rates in the clinical
trials of another drug and may not reflect the rates observed in
practice.
In clinical trials 467 patients were treated with Altoprev with mean exposure of approximately 11.6 weeks. The mean age of the population was 56 years, 43% of the population were female, 86% were White, 6% were Black or African American, 1% were Asian, and 7% were other races [see Clinical Studies (14)]. Adverse reactions occurring in >5% of patients in any treatment group are shown in Table 2 below.
…
Elevations in Liver Enzyme Tests
In the AFCAPS/TexCAPS study, 6,605 patients were treated with lovastatin immediate-release (n=3,304) or placebo (n=3,301). Patients with consecutive elevations of either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (>3 times ULN), over a median of 5.1 years of follow-up, was not significantly different between the lovastatin immediate-release and placebo groups. Elevated transaminases resulted in discontinuation of 6 (0.2%) patients from therapy in the lovastatin immediate-release group and 4 (0.1%) in the placebo group.
In the EXCEL study, the incidence of persistent increases in serum transaminases over 48 weeks was 0.1% for placebo, 0.1% at 20 mg daily, 0.9% at 40 mg daily, and 1.5% at 80 mg daily in patients treated with lovastatin immediate-release (not an approved dose of Altoprev) [see Dosage and Administration (2.2)].
6.2 Postmarketing Experience
Additions and/or
revisions underlined:
The
following adverse reactions have been identified during post-approval use of
Altoprev. Because these reactions
are reported voluntarily from a population of uncertain size,
it is not always possible to reliably estimate
their frequency or establish a causal relationship to drug exposure.
Skeletal: muscle cramps, myopathy, rhabdomyolysis. There have been rare reports of immune- mediated necrotizing myopathy associated with statin use.
Neurological: dysfunction of certain cranial nerves (including alteration of taste, impairment of extra-ocular movement, facial paresis), tremor, vertigo, paresthesia, peripheral neuropathy, peripheral nerve palsy, psychic disturbances, anxiety, insomnia, depression.
There have been rare post marketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks). There have been rare reports of new-onset or exacerbation of myasthenia gravis, including ocular myasthenia, and reports of recurrence when the same or a different statin was administered.
Hypersensitivity Reactions: An apparent hypersensitivity syndrome has been reported rarely which has included one or more of the following features: anaphylaxis, angioedema, lupus erythematous-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, urticaria, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome.
Gastrointestinal: pancreatitis, hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in liver; and rarely, cirrhosis, fulminant hepatic necrosis, and hepatoma; anorexia, vomiting, fatal and non-fatal hepatic failure.
Skin: alopecia, pruritus, lichen planus. A variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails) have been reported.
Reproductive: gynecomastia, loss of libido, erectile dysfunction.
Eye: progression of cataracts (lens opacities), ophthalmoplegia.
Laboratory Abnormalities: alkaline phosphatase, ?-glutamyl transpeptidase, and bilirubin; thyroid function abnormalities.
Respiratory: interstitial lung disease.
7 Drug Interactions
Extensive changes; please refer to label for complete information
8 Use in Specific Populations
8.1 Pregnancy
Additions and/or revisions underlined:
Risk Summary
Discontinue Altoprev when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Altoprev decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, Altoprev may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1)]. In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients.
Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. Published data from prospective and retrospective observational cohort studies with lovastatin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data). In animal reproduction studies, no teratogenic effects were observed in pregnant rats, mice or rabbits orally administered lovastatin at doses that resulted in up to 25, 5, and 4 times, respectively, the human exposure at the maximum human dose of 80 mg lovastatin immediate-release based on body surface area (mg/m2) (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Human Data
A Medicaid cohort linkage study of 1,152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity scorebased methods. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births.
Animal Data
In pregnant rats given oral gavage doses of 100, 200, 400, 800 mg/kg/day lovastatin from gestation days 6 through 20 during the period of organogenesis, reduced fetal body weights were observed at all doses and skeletal malformations were observed at greater than or equal to 400 mg/kg/day, corresponding to 50 times the 80 mg/day -release maximum human dose, based on body surface area (mg/m2).
In pregnant mice given oral gavage doses of 8, 80, 800 mg/kg/day lovastatin from gestation days 6 through 15 during the period of organogenesis, reduced fetal body weights were observed at greater than or equal to 80 mg/kg/day and skeletal malformations were observed at 800 mg/kg/day, corresponding to 5 and 50 times the 80 mg/day lovastatin immediate-release maximum human dose, based on body surface area (mg/m2).
In pregnant rabbits given an oral gavage dose of 15 mg/kg/day lovastatin from gestation days 6 through 18 during the period of organogenesis, no teratogenic effects were observed. Doses were 4 times the 80 mg/day lovastatin immediate-release maximum human dose, based on body surface area (mg/m2).
In pregnant rats given oral gavage doses of 2, 20, 200 mg/kg/day lovastatin by oral gavage from gestation day 15 through lactation day 21 (weaning), increased mortality of offspring was observed at greater than or equal to 20 mg/kg/day and development delays were observed at 200 mg/kg/day, corresponding to 2.4 and 24 times, respectively, the 80 mg/day lovastatin immediate-release maximum human dose, based on body surface area (mg/m2).
8.2 Lactation
Additions and/or
revisions underlined:
Risk Summary
There is no information about the presence of lovastatin in human or animal milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. However, it has been shown that another drug in this class passes into human milk. Statins, including Altoprev, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant.
Because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with Altoprev [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.1)].
8.4 Pediatric Use
Additions and/or
revisions underlined:
The safety and effectiveness of Altoprev have not been established in
pediatric patients.
8.5 Geriatric Use
Additions and/or
revisions underlined:
Of
the 467 patients who received Altoprev in clinical studies, 18% were 65 years
and older. In the clinical studies conducted with lovastatin
immediate-release (EXCEL and AFCAPS/TexCAPS), 21% (3094/14850) of patients were
greater than or equal to 65 years of age. In pharmacokinetic
studies with lovastatin immediate-release, the mean plasma level of HMG-CoA
reductase inhibitory activity was shown to be approximately 45% higher in elderly patients
between 70-78 years of age
compared with patients between 18-30 years of age [see Clinical Pharmacology (12.3)].
Advanced age (greater than or equal to 65 years) is a risk factor for Altoprev-associated myopathy and rhabdomyolysis. Dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. Monitor geriatric patients receiving Altoprev for the increased risk of myopathy [see Warnings and Precautions (5.1)].
8.6 Renal Impairment
Additions and/or
revisions underlined:
In a study of patients with severe renal impairment (creatinine clearance 10–30 mL/min),
the plasma concentrations of total
inhibitors after a single dose of lovastatin were approximately
two-fold higher than those in healthy volunteers.
Renal impairment is a risk factor for myopathy and rhabdomyolysis.
Monitor all patients with renal impairment for development of myopathy. In
patients with severe renal impairment, consider if the benefits
of increasing the dosage above 20 mg daily outweighs the increased risk of myopathy and rhabdomyolysis [see Dosage and Administration (2.3),
Warnings and Precautions (5.1), and Clinical Pharmacology (12.3)].
8.7 Hepatic Impairment
Newly added subsection:
Altoprev is contraindicated in patients with acute liver failure or decompensated cirrhosis [see Contraindications (4) and Warnings and Precautions (5.3)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATIONAdditions and/or
revisions underlined:
Myopathy and Rhabdomyolysis
Advise patients that Altoprev may cause myopathy and rhabdomyolysis. Inform patients that the risk is also increased when taking certain types of medication or consuming grapefruit juice and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions (5.1), Drug Interactions (7.1)].
Hepatic Dysfunction
Inform patients that Altoprev may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Warnings and Precautions (5.3)].
Increases in HbA1c and Fasting Serum Glucose Levels
Inform patients that increases in HbA1c and fasting serum glucose levels may occur with Altoprev. Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices [see Warnings and Precautions (5.4)].
Pregnancy
Advise pregnant patients and patients who can become pregnant of the potential risk to a fetus. Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if Altoprev should be discontinued [see Use in Specific Populations (8.1)].
Lactation
Advise patients that breastfeeding is not recommended during treatment with Altoprev [see Use in Specific Populations (8.2)].
Missed Dose
Instruct patients to take Altoprev only as prescribed. If a dose is missed, it should be taken as soon as possible. Advise patients not to double their next dose.
09/25/2020 (SUPPL-36)
5 Warnings and Precautions
5.2 Immune-Mediated Necrotizing Myopathy(New subsection added)
There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMGCoA reductase antibody; muscle biopsy showing necrotizing myopathy and improvement with immunosuppressive agents.
Additional
neuromuscular and serologic testing may be necessary. Treatment with
immunosuppressive agents may be required. Consider risk of IMNM carefully prior
to initiation of a different statin. If therapy is initiated with a different
statin, monitor for signs and symptoms of IMNM.
02/28/2018 (SUPPL-35)
4 Contraindications
(Additions and/or revisions are underlined)
The use of Altoprev is contraindicated in the following conditions:
- Pregnancy.
- Lactation. Because another drug in this class passes into breast milk, and because statins have the potential to cause serious adverse reactions in breastfed infants, women who require Altoprev treatment should not breastfeed their infants.
7 Drug Interactions
(Additions and/or revisions are underlined)
Drug interaction studies have not been performed with Altoprev. The types, frequencies and magnitude of drug interactions that may be encountered when Altoprev is administered with other drugs may differ from the drug interactions encountered with the lovastatin immediate- release formulation…
8 Use in Specific Populations
8.1 Pregnancy
(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)
Risk Summary
Altoprev is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy with Altoprev during pregnancy. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, Altoprev may cause fetal harm when administered to pregnant women. Altoprev should be discontinued as soon as pregnancy is recognized . Limited published data on the use of lovastatin are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. In animal reproduction studies, no evidence of fetal malformations was seen in mice or rats at doses 5 and 25 times, respectively, the maximum recommended human dose (MRHD) of 80 mg/day lovastatin immediate-release, based on body surface area. No evidence of malformations was noted in rabbits with oral administration of lovastatin during organogenesis at doses up to 4 times the MRHD, based on body surface area. Skeletal malformations occurred at doses 50 times the MRHD in mice and rats, based on body surface area.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Human Data
Limited published data on lovastatin have not shown an increased risk of major congenital malformations or miscarriage.
Rare reports of congenital anomalies have been received following intrauterine exposure to other statins. In a review of approximately 100 prospectively followed pregnancies in women exposed to simvastatin or lovastatin, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed what would be expected in the general population. The number of cases is adequate to exclude a greater than or equal to 3 to 4-fold increase in congenital anomalies over the background incidence…
Animal Data
In pregnant rats given oral gavage doses of 100, 200, 400, 800 mg/kg/day lovastatin from gestation days 6 through 20, reduced fetal body weights were observed at all doses and skeletal malformations were observed at greater than or equal to 400 mg/kg/day, corresponding to 50 times the 80 mg/day MRHD of lovastatin immediate-release, based on body surface area (mg/m2).
In pregnant mice given oral gavage doses of 8, 80, 800 mg/kg/day lovastatin from gestation days 6 through 15, reduced fetal body weights were observed at greater than or equal to 80 mg/kg/day and skeletal malformations were observed at 800 mg/kg/day, corresponding to 5 and 50 times the 80 mg/day MRHD, based on body surface area (mg/m2).
In pregnant rabbits given an oral gavage dose of 15 mg/kg/day lovastatin from gestation days 6 through 18, no teratogenic effects were observed. Doses were 4 times the 80 mg/day MRHD, based on body surface area (mg/m2).
In pregnant rats given oral gavage doses of 2, 20, 200 mg/kg/day lovastatin by oral gavage from gestation day 15 through lactation day 21 (weaning), increased mortality of offspring was observed at greater than or equal to 20 mg/kg/day and development delays were observed at 200 mg/kg/day, corresponding to 2.4 and 24 times, respectively, the 80 mg/day MRHD, based on body surface area (mg/m2).
(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)
Risk Summary
Altoprev is contraindicated during breastfeeding. There is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. However, a small amount of another drug in this class is present in human breast milk. Because of the potential for serious adverse reactions in breastfed infants, advise patients that breastfeeding is not recommended during treatment with Altoprev.
(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)
Contraception
Altoprev may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with Altoprev.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions are underlined)
Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment, and to inform their healthcare provider of a known or suspected pregnancy.
(Additions and/or revisions are underlined)
Advise women not to breastfeed during treatment with Altoprev.
08/04/2017 (SUPPL-34)
6 Adverse Reactions
6.2 Postmarketing ExperienceAddition of the following:
Respiratory: interstitial lung disease
7 Drug Interactions
Additions and/or revisions underlined
… In addition, as the drug exposure with Altoprev® 60 mg is greater than that with lovastatin immediate-release 80 mg (maximum recommended dose), the severity and magnitude of drug interactions that may be encountered with Altoprev® 60 mg are not known. It is therefore recommended that the following precautions and recommendations for the concomitant administration of lovastatin immediate-release with other drugs …