Polidocanol

Pregnancy Category: C

Shown to have an embryocidal effect in rabbits when given in doses approximately equal (on the basis of body surface area) to the human dose; this effect may have been secondary to maternal toxicity

No adequate and well-controlled studies in pregnant women should not be used during pregnancy

Lactation: Unknown whether distributed in breast milk, not recommeded

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Serious side effects have been reported with polidocanol including the following:

• Severe allergic reaction. Tell your healthcare provider right away if you have some or all of the following symptoms of a severe allergic reaction:
  • difficulty breathing or tightness in the throat or chest
  • decreased heart rate, chest pain, or lightheadedness
  • hives, swelling, or rash
  • confusion, headache, slurred speech
• Polidocanol can cause dizziness. Do not drive or operate heavy machinery until you know how polidocanol affects you.

Do not take polidocanol if you: 

• are allergic to polidocanol or to any of its ingredients
• have acute thromboembolic disease

If polidocanol is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if polidocanol crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using polidocanol.

• Store polidocanol at room temperature between 59° and 86°F (15° - 30° C).
• Varithena (polidocanol) contains gas under pressure and may explode if heated. Store in a well-ventilated place, away from sources of heat.
• Keep this and all medicines out of the reach of children.

Contraindications

• Known allergy (anaphylaxis) to polidocanol.1 (See Sensitivity Reactions under Cautions.)

• Acute thromboembolic diseases.1

Warnings/Precautions

Sensitivity Reactions

Severe allergic reactions (e.g., anaphylactic reactions), including some fatalities, reported.1 Severe reactions more frequent with larger volumes (>3 mL).1 Use minimal required dose.1

Postmarketing reports of allergic dermatitis, angioedema, generalized urticaria, and asthma.1

Observe patient for 15–20 minutes after polidocanol treatment session in case an anaphylactic or allergic reaction occurs.1 Clinicians should be prepared to provide appropriate treatment of anaphylaxis.1

Administration Precautions

Extravasation may result in severe adverse local effects, including tissue necrosis.1 Carefully place IV needle into target vein;1 use smallest effective volume of solution at each injection site.1 Overdosage may result in higher incidence of localized reactions such as necrosis.1

After polidocanol treatment session, apply compression to treatment area with a stocking or bandage and have patient walk for 15–20 minutes.1 (See IV Administration under Dosage and Administration.) Supervise patient during this period in case an anaphylactic or allergic reaction occurs.1 (See Sensitivity Reactions under Cautions.)

Accidental intra-arterial injection may cause severe necrosis, ischemia, or gangrene.1 Immediately consult vascular surgeon if occurs.1

Inadvertent perivascular injection can cause pain.1 If pain is severe, a local anesthetic (without adrenaline) may be injected.1

Specific Populations

Category C. 1

Do not use during pregnancy.1

Effects on labor and delivery unknown.1

Not known whether distributed into human milk.1 Potential for serious adverse reactions in nursing infants; avoid use in nursing women.1

Safety and efficacy not established in pediatric patients.1

Insufficient experience in patients ≥65 years to determine whether geriatric patients respond differently than younger adults.1

Common Adverse Effects

Injection site reactions including hematoma, irritation, discoloration, pain, pruritus, warmth, neovascularization, thrombosis.1

No drug interaction studies.1

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Foam, Intravenous:

Varithena: 180 mg/18 mL (45 mL) [contains alcohol, usp]

Solution, Intravenous [preservative free]:

Asclera: 0.5% (2 mL); 1% (2 mL) [contains alcohol, usp]

Varicose veins:

Asclera: Treatment of uncomplicated spider veins (varicose veins 1 mm or less in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity.

Varithena: Treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system above and below the knee.

For intravenous use only. Avoid extravasation and intra-arterial injection.

Asclera: Administer using a syringe with 26 or 30-gauge needle. Insert the needle tangentially into the vein and inject slowly while the needle is still in the vein; apply gentle pressure during injection to prevent vein rupture. After the needle has been removed and the injection site has been covered, apply compression in the form of a stocking or bandage (maintain for 2 to 3 days [spider veins] and 5 to 7 days [reticular veins]); longer compression is recommended for extensive varicosities. After applying compression, patient should walk for 15 to 20 minutes and be observed for anaphylactic or allergic reaction.

Varithena: Administer via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into the varicosities within 75 seconds of extraction from canister; use a new sterile syringe after each injection. Do not use syringe if visible bubbles present. A local anesthetic may be administered prior to cannula insertion. Inject slowly (~1 mL/second in great saphenous vein and 0.5 mL/second in accessory veins or varicosities) using ultrasound guidance. Confirm venospasm of the treated vein. When treating the proximal great saphenous vein, stop the injection when polidocanol is 3 to 5 cm distal to the saphenofemoral junction. After injection, apply compression in the form of a stocking or bandage (maintain for 2 weeks) and have patient walk for ≥10 minutes while under observation.

Adverse events have been observed in animal reproduction studies. Do not use polidocanol during pregnancy.