Oxlumo Side Effects Center

Last updated on RxList: 7/21/2021
Oxlumo Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Oxlumo?

Oxlumo (lumasiran) is a HAO1-directed small interfering ribonucleic acid (siRNA) used to treat primary hyperoxaluria type1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

What Are Side Effects of Oxlumo?

Side effects of Oxlumo include:

  • injection site reactions (redness, pain, itching, and swelling) and
  • abdominal pain

Dosage for Oxlumo

The recommended dosing regimen of Oxlumo consists of loading doses followed by maintenance doses. The recommended dose of Oxlumo by subcutaneous injection is based on the patient's body weight.

Oxlumo In Children

The safety and effectiveness of Oxlumo have been established in pediatric patients aged birth and older.

What Drugs, Substances, or Supplements Interact with Oxlumo?

Oxlumo may interact with other medicines.

Tell your doctor all medications and supplements you use.

Oxlumo During Pregnancy and Breastfeeding

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

Additional Information

Our Oxlumo (lumasiran) Injection, for Subcutaneous Use 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.

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

The only purpose of the kidneys is to filter blood. See Answer
Oxlumo 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.

Common side effects may include pain, redness, itching, or swelling where the medicine was injected.

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 Oxlumo (Lumasiran Injection)

SLIDESHOW

Kidney Stones: Symptoms, Causes, and Treatment See Slideshow
Oxlumo Professional Information

SIDE EFFECTS

Clinical Trials Experience

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.

The data reflect placebo-controlled and open-label clinical studies in 77 patients with PH1 (including 56 pediatric patients). Patients ranged in age from 4 months to 61 years at first dose. The median duration of exposure was 9.1 months (range 1.9 to 21.7 months). Overall, 58 patients were treated for at least 6 months, and 18 patients for at least 12 months.

In the randomized, placebo-controlled, double-blind study ILLUMINATE-A in pediatric and adult patients with PH1 aged 6 to 61 years, 26 patients received OXLUMO and 13 patients received placebo. Of these, 25 patients received ≥5 months of treatment. The most common (≥20%) adverse reaction reported was injection site reaction. Injection site reactions occurred throughout the study period and included erythema, pain, pruritus, and swelling. These symptoms were generally mild and resolved within one day of the injection and did not lead to discontinuation of treatment.

In the single-arm study (ILLUMINATE-B) in patients with PH1 who are <6 years of age, the safety profile observed was similar to that seen in ILLUMINATE-A [see Clinical Studies].

Table 2: Adverse Reactions Reported in at Least 10% of Patients Treated with OXLUMO and that Occurred at Least 5% More Frequently than in Patients Treated with Placebo in ILLUMINATE-A during the 6-Month Double-Blind Period

Adverse ReactionOXLUMO
N=26
N (%)
Placebo
N=13
N (%)
Injection site reaction10 (38)0 (0)
Abdominal pain*4 (15)1 (8)
*Grouped term includes abdominal pain, abdominal pain upper, abdominal pain lower, and abdominal discomfort

Immunogenicity

As with all oligonucleotides, including OXLUMO, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

Across all clinical studies in the lumasiran development program, including patients with PH1 and healthy volunteers dosed with OXLUMO, 6 of 100 (6%) lumasiran-treated individuals with mean follow-up duration of 8.9 months, tested positive for anti-drug antibodies (ADA), as early as from Day 29. No clinically significant differences in the safety, pharmacokinetic, or pharmacodynamic profiles of lumasiran were observed in patients who tested positive for anti-lumasiran antibody.

Read the entire FDA prescribing information for Oxlumo (Lumasiran Injection)

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

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