What are the most common side effects of CEMIPLIMAB-RWLC?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for CEMIPLIMAB-RWLC. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is CEMIPLIMAB-RWLC the same as LIBTAYO?

LIBTAYO is a brand name for CEMIPLIMAB-RWLC. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

CEMIPLIMAB-RWLC

Q: What is CEMIPLIMAB-RWLC used for?

CEMIPLIMAB-RWLC (brand name LIBTAYO) is a Immune Checkpoint Inhibitor indicated for with no EGFR, ALK or ROS1 aberrations, and is: locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or metastatic. ( 1.3.

Q: How does CEMIPLIMAB-RWLC work?

CEMIPLIMAB-RWLC works through the following mechanism: 12.1 Mechanism of Action Binding of the PD-1 ligands PD-L1 and PD-L2 to the PD-1 receptor found on T cells inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Cemiplimab-rwlc is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth..

Immune Checkpoint Inhibitor

Brand names: LIBTAYO

Intravenous

Mechanism of Action

12.1 Mechanism of Action Binding of the PD-1 ligands PD-L1 and PD-L2 to the PD-1 receptor found on T cells inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Cemiplimab-rwlc is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.

Indications

with no EGFR

ALK or ROS1 aberrations

and is: locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or metastatic. ( 1.3

with no EGFR

ALK or ROS1 aberrations

and is: locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or metastatic.

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Immune-Mediated Adverse Reactions ( 5
1 ) Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection
2 ) Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT): Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody
Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception

Known Side Effects

9 documented side effects by frequency

Fatigue

1-10%

Rash

1-10%

Shortness of Breath

1-10%

Fever

1-10%

Itching

0.1-1%

Weakness

0.1-1%

Diarrhea

0.1-1%

Nausea

0.1-1%

Drug Not Working

0.1-1%

Community Discussions

1 Reddit threads analysed for CEMIPLIMAB-RWLC

Overall Sentiment

Mixed

Comparison Threads

Avg Post Score

20 upvotes

Most discussed side effects in community

Muscle Pain (1)

Sexual Dysfunction (1)

Patient Experiences (r/pharmacy, r/AskDocs & more)

Your Morning Coffee: 10/09/2018

# EARNINGS Helen of Troy (HELE) Q2 Adj. EPS USD 1.98 vs. Exp. USD 1.60, revenue USD 393.55mln vs. Exp. USD 349.19mln; raises FY19 Adj. EPS USD 7.65-7.90 vs. Exp. USD 7.62. (Newswires) #DJIA Apple (AAPL) – The behemoth’s 2018 iPad Pro models are to include edge-to-edge displays, Face ID, USB

r/wallstreetbets2017y ago

Muscle Pain

Sexual Dysfunction

Community discussions are sourced from public Reddit threads. Content reflects individual opinions and is not medical advice.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → CEMIPLIMAB-RWLC openFDA label JSON → CEMIPLIMAB-RWLC FAERS adverse-event reports → CEMIPLIMAB-RWLC ClinicalTrials.gov → completed Phase 2+ trials of CEMIPLIMAB-RWLC

Compare With

5 available comparisons

Formulations

Dosage Forms

Tablet

Route

Intravenous