APMA News - November/December 2021 - 70

Methemoglobinemia: Cases have been reported with local
anesthetic use.
Serious Skin Reactions: NSAIDs, including meloxicam, can cause
serious skin adverse reactions. If symptoms present, evaluate
clinically.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS):
If symptoms are present, evaluate clinically.
Fetal Toxicity: Due to the risk of oligohydramnios/fetal renal
dysfunction and premature closure of the ductus arteriosus with
NSAIDS, limit use of ZYNRELEF between about 20 to 30 weeks
gestation, and avoid use after about 30 weeks.
Hematologic Toxicity: Monitor hemoglobin and hematocrit in
patients with any signs or symptoms of anemia.
Drug Interactions
Drugs That Interfere with Hemostasis: Monitor patients for bleeding
who are using ZYNRELEF with drugs that interfere with hemostasis
(eg, warfarin, aspirin, SSRIs/SNRIs).
ACE Inhibitors, Angiotensin Receptor Blockers (ARBs), or BetaBlockers:
Use with ZYNRELEF may diminish the antihypertensive
effect of these drugs. Monitor blood pressure.
ACE Inhibitors and ARBs: Use with ZYNRELEF in elderly, volumedepleted,
or those with renal impairment may result in deterioration
of renal function. In such high-risk patients, monitor for signs of
worsening renal function.
Diuretics: NSAIDs can reduce natriuretic effect of furosemide
and thiazide diuretics. Monitor patients to assure diuretic efficacy
including antihypertensive effect.
Use in Specific Populations
Infertility: NSAIDs are associated with reversible infertility. Consider
avoidance of ZYNRELEF in women who have difficulties conceiving.
Severe Hepatic Impairment: Only use if benefits are expected to
outweigh risks; monitor for signs of worsening liver function.
Severe Renal Impairment: Not recommended.
Adverse Reactions
Most common adverse reactions (incidence ≥10%) in controlled
clinical trials with ZYNRELEF are constipation, vomiting, and
headache.
Report side effects to Heron at 1-844-437-6611 or to FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
For additional information about ZYNRELEF, please refer to the
Brief Summary of Prescribing Information on adjacent page.
References: 1. ZYNRELEF [package insert]. San Diego, CA: Heron Therapeutics Inc;
2021. 2. Viscusi E, Gimbel JS, Pollack RA, Hu J, Lee G-C. HTX-011 reduced pain intensity
and opioid consumption versus bupivacaine HCl in bunionectomy: Phase III results
from the randomized EPOCH 1 study. Reg Anesth Pain Med. 2019;44(7):700-706.
doi:10.1136/rapm-2019-100531. 3. Viscusi E, Minkowitz H, Winkle P, Ramamoorthy S,
Hu J, Singla N. HTX-011 reduced pain intensity and opioid consumption versus
bupivacaine HCl in herniorrhaphy: results from the Phase 3 EPOCH 2 study. Hernia.
2019;23(6):1071-1080. doi:10.1007/s10029-019-02023-6. 4. Lachiewicz PF, Lee G-C,
Pollak R, Leiman D, Hu J, Sah A. HTX-011 reduced pain and opioid use after primary
total knee arthroplasty: results of a randomized Phase 2b trial. J Arthroplasty.
2020;35(10):2843-2851. doi:10.1016/j.arth.2020.05.044. 5. Ottoboni T, Quart B,
Pawasauskas J, Dasta JF, Pollak RA, Viscusi ER. Mechanism of action of HTX-011: a
novel, extended-release, dual-acting local anesthetic formulation for postoperative pain.
Reg Anesth Pain Med. 2020;45(2):117-123. doi:10.1136/rapm-2019-100714.
REDEFINE POSTOPERATIVE PAIN MANAGEMENT
http://www.fda.gov/medwatch
APMA News - November/December 2021

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