Supartz FX Side Effects Center

Last updated on RxList: 6/14/2022
Supartz FX Side Effects Center

What Is Supartz FX?

Supartz FX (sodium hyaluronate) is a cartilaginous defect repair agent indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.

What Are Side Effects of Supartz FX?

Common side effects of Supartz FX include:

  • joint pain,
  • arthritis,
  • back pain,
  • pain (non-specific),
  • injection site reaction (inflammation or red or purple discoloration),
  • headache, and
  • injection site pain

Dosage for Supartz FX

The dose of Supartz FX is an intra-articular injection once a week (1 week apart) for a total of 5 injections. Some patients may experience benefit with 3 injections given at weekly intervals.

What Drugs, Substances, or Supplements Interact with Supartz FX?

Supartz FX may interact with other drugs. Tell your doctor all medications and supplements you use.

Supartz FX During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Supartz FX; it is unknown how it would affect a fetus. It is unknown if Supartz FX passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Supartz FX (sodium hyaluronate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

What joints are most often affected by osteoarthritis? See Answer
Supartz FX Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe pain or swelling around the knee after the injection.

Common side effects may include:

  • warmth, pain, redness, stiffness, bruising, or puffiness where the medicine was injected;
  • nausea, stomach pain;
  • trouble walking;
  • swelling in your hands or feet;
  • back pain, joint pain, muscle pain;
  • numbness or tingly feeling;
  • headache, dizziness; or
  • runny or stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Supartz FX (Sodium Hyaluronate Solution)

SLIDESHOW

Slideshow: Exercises for Knee Osteoarthritis and Joint Pain See Slideshow
Supartz FX Professional Information

SIDE EFFECTS

The evaluable for safety population included all patients receiving at least one injection (532 SUPARTZ FX 5; 87 SUPARTZ FX 3; 537 control injection) in five well controlled clinical trials. The most common adverse events occurring in SUPARTZ FX-treated patients were arthralgia, defined as joint pain with no evidence of inflammation, arthropathy/ arthrosis/arthritis, defined as joint pain with evidence of inflammation, back pain, pain (non-specific), injection site reaction, headache, and injection site pain (See Table 1). There were no statistically significant differences in the incidence rates of these adverse events between treatment groups.

Five (5) allergic reactions were reported in the SUPARTZ FX group. All five events were classified as mild to moderate. These were: hayfever (2), reaction on face and neck, cutaneous reaction forearms and knees, and an undefined mild allergy reaction. No anaphylactic reactions were observed in any study patients. Other adverse events occuring in 4% or less but not less than 1% of the SUPARTZ FX treated patients included upper respiratory tract infection, influenza-like symptoms, nausea, sinusitis, urinary tract infection, bronchitis, abdominal pain, diarrhea, inflicted injury, leg pain, discomfort in legs, dyspepsia, dizziness, rhinitis, and fall.

SUPARTZ FX (ARTZ) has been in use in Japan since 1987. A prospective post-market surveillance study1 conducted from 1987 to 1993 evaluated safety on 7404 knees treated from a total of 675 medical institutions. A subset of 7155 knees was treated with 3 or more consecutive injections. There were 58 cases of adverse reactions in 37 knees (0.50% - 37/7404). The most frequently observed were 29 cases of pain at the injection site, 16 cases of swelling, and 3 cases of redness. Other adverse reactions were 3 cases of rash, 3 cases of increased serum GPT, 2 cases of increased serum GOT, 1 case of itching, and 1 case of increased Al-P. The incidence of adverse reactions was not related to the number of injections. There was no increase in adverse events in patients requiring 3 or more injections.

Adverse experience data from the literature contain no evidence of increased safety risk relating to retreatment with SUPARTZ FX. The frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle.

Post-Market Experience

The following possible adverse reactions have been reported worldwide.

  • The most common adverse reactions include: Injection site reactions (pain / swelling / effusion / redness / warmth). Rare cases of severe reactions have been reported.
  • Other adverse reactions include: Itching; swelling of the face, eyelids, mouth and/or extremities; rash; hives; redness in face; nausea; vomiting and fever. Anaphylactic/anaphylactoid reactions accompanied by transient hypotension (sudden drop in blood pressure), have been rarely reported, all of which resolved either spontaneously or after conservative treatment.

Table 1: Adverse Events Occurring in > 4% of SUPARTZ FXtreated Patients

Integrated Safety Database SUPARTZ FX
(n=619)
Control
(n=537)
n % n %
Arthralgia 110 17.8% 95 17.7%
Arthropathy/Arthrosis/Arthritis 68 11.0% 57 10.6%
Back Pain 40 6.5% 26 4.8%
Pain (non-specific) 37 6.0% 26 4.8%
Injection Site Reaction* 35 5.7% 18 3.4%
Headache 27 4.4% 23 4.3%
Injection Site Pain 26 4.2% 22 4.1%
*Includes application/injection site reaction, injection site inflammation, and purpura injection site.

Table 1A: Adverse Events Occurring in 3-Injection SUPARTZ FX-treated Patient

Adverse Event Type French Study
Number (%) of Patients Receiving Control Injections
(N=80)
Number (%) of Patients Receiving SUPARTZ FX-3
(N=87)
Arthralgia 12(15.0%) 11(12.6%)
Arthropathy, Arthrosis or Arthritis 3(3.8%) 1(1.1%)
Back Pain 10(12.5%) 10(11.5%)
Pain 16(20.0%) 16(18.4%)
Injection Site Reaction* 0(0.0%) 1(1.1%)
Headache 4(5.0%) 3(3.4%)
Injection Site Pain 4(5.0%) 3(3.4%)
*Includes application/injection site reaction, injection site inflammation, and purpura injection site.

Read the entire FDA prescribing information for Supartz FX (Sodium Hyaluronate Solution)

© Supartz FX Patient Information is supplied by Cerner Multum, Inc. and Supartz FX Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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